Longevity Industry Jobs

Amylyx is growing as a global company. We are committed to the patient communities which we have the pleasure to be a part of improving the lives of patients living with progressive diseases. The build of our R&D pipeline through a combination of internally developed programs and external collaboration across academia, biotech and pharmaceutical partners is foundational to the continued growth of Amylyx in our mission to serve patients. We are seeking a life science industry professional that has a strong scientific background and acumen equally matched by their fervent interest and dedication to seek and develop therapeutics with the potential to impact patients suffering from relentless neurodegenerative and neuromuscular disease(s).

RESPONSIBILITIES:

The core responsibility of the Lead, R&D Business Development and Evaluation is to monitor, source and diligence promising therapeutic opportunities and related technologies within our disease area of focus. R&D / BD strategy is emerging on the heels of our first drug approval and this high impact role would entail:

• Proactively lead the scouting of external pipeline opportunities ranging from academic research, private and public biotech through to pharmaceuticals.
• Conduct initial Tier 1 scientific diligence and the follow-on diligence process, coordinating with internal resource and external advisors / experts.
• Act as the lead point of contact with potential external partners regarding all scientific matters
• Work collaboratively with key stakeholders across the organization including (but not limited to) the executive leadership team, R&D, Legal and Finance to assess opportunities and their potential strategic fit for the Company’s near and long-term vision and goals.
• Represent the Company to the external community, participating in key scientific conferences and diligence outreach to academic, venture, and industry leaders. The Company has been successful embedding ourselves in the core disease areas of interest. We look for this team member to do the same, driven by intellectual curiosity.
• In coordination with the BD team, establish and continually seek to optimize the process, approach and efficiency to which we source and review opportunities.
• In coordination with the Head of BD and executive leadership team, collaborate in the structuring of partnerships that appropriately weigh risk and opportunity.

REQUIREMENTS:

• Bachelors degree in life sciences / medicine
• Advanced degree (MS, PhD, PharmD, MD) preferred
• 8+ years of relevant industry (R&D, BD, Strategy) or consulting / competitive intelligence experience
• Strong knowledge of the biotech / pharma industry; preferably well versed in rare / neuro research.
• Superb communication skills in being able to present the company’s strategy externally as well as communicate opportunities internally in a succinct, accurate manner
• Insatiable appetite to continue to learn and a willingness to seek information across various pockets of the organization or scientific circles
• Willingness to travel as needed for onsite diligence and participation in scientific / partnering conferences (10-20%)

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is seeking an accomplished collaborative and inclusive Lead, Regulatory Affairs EMEA (Europe, Middle East and Africa) to further build and expand the regulatory affairs function at Amylyx. In this role, you will be responsible for bringing EMEA requirements into global regulatory strategies to support the development and commercialization of Amylyx products in all phases of clinical development and life-cycle management. You will be responsible for implementing the regional aspects of strategic regulatory plans to enable continued compliance in EMEA. You will coordinate the preparation of high-quality regulatory submissions to regional regulatory agencies and act as the company regulatory representative for regional regulatory agencies.

The Lead, Regulatory Affairs EMEA will work closely with the Lead(s), Global regulatory affairs and act as the EMEA regulatory representative towards internal and external teams from Clinical Development and Operations, Pharmacovigilance, Medical Affairs, and external regulatory consultants to advance the Company’s portfolio. You will be the primary point of contact for stakeholders related to regulatory affairs in the EMEA region for assigned products and projects.

The role will report to the Head, Regulatory Affairs EMEA.

Responsibilities

• Develop and implement EMEA regulatory strategies in line with the global regulatory strategy aimed at gaining the earliest possible regulatory approval as well as subsequent regulatory strategies for label optimisation and product life cycle management.
• Lead the preparation of high-quality, on-time regional regulatory submissions/briefing packages, such as for clinical trial applications, EMA and NCA scientific advice, orphan drug applications, paediatric investigation plans, initial MAAs and post-approval life cycle management.
• Coordinate and conduct regulatory agency meetings in the EMEA region.
• Contribute to the review and approval of product labelling, promotional claims and advertising to ensure compliance with corporate policy, European and international laws and regulations.
• Develop and implement the regulatory submission strategy for second and third wave countries in the EMEA region.
• Partner closely with regional EMEA functions of the Company, including medical, pharmacovigilance, market access, supply chain and quality assurance, as well as with global R&D and technical operations functions.
• Work with external regulatory consultants, CROs and other partners to manage assigned submission activities as needed.
• Maintain knowledge of European regulatory requirements and advise internal stakeholders on emerging regulatory trends.
• Help establish relevant processes and procedures to support Regulatory Affairs function activities.
• Ensure compliance with all regulatory requirements.

Requirements

• Bachelor’s degree and equivalent medical professional experience in chemistry, biochemistry, or pharmacy.
• Minimum 8 years of Regulatory experience or related areas. Some Regulatory CMC experience a plus.
• Experience working within Sponsor organizations.
• Evidence of successful regulatory submissions to EMA and national competent authorities (e.g., CTA, scientific advice, orphan drug designation PIP, initial MAA, variations).
• Knowledge of EU, US, and international regulatory standards and guidelines is a must.
• Strong analytical and report writing skills.
• Must have excellent professional written and oral communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
• Self-confident, autonomous, ability to build positive relationships.
• Convinced and ambassador of the Company core values – Audacious, curious, engaged, accountable & authentic.

The position is based in any western EU country and will require some travel in Europe (20%).

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is seeking a Brand Designer to support business units across the organization on various deliverables, including power point presentations, infographics, marketing collateral and internal communications. The Brand Designer will be responsible for the conceptual development, direction, and delivery of visual design based on established brand guidelines from ideation to completion. This individual will have the technical expertise to create visually compelling content that distinguishes Amylyx in the marketplace while maintaining best practice, optimization, and consistency. In addition, this individual will execute discreet design studio requests within existing creative files (minor copy updates, design changes, resizing, etc.) This role will report to the Head of Global Digital Strategy.

RESPONSIBILITIES:

• Collaborate closely with Marketing, Corporate Communications, sales, market access, training, and others to develop and refine key presentations and one-sheets
• Develop stunning PowerPoint presentations from manuscript to layout that creatively impact the company at a high level all while maintaining brand compliance
• Produce infographics, and update materials that captures an audience and drives clear objectives
• Support brand team on visual enhancements/updates to existing webpages
• Educate stakeholders on the latest trends and designs for information presentation and provide recommendations based on best practices
• Identify opportunities to organize and update the design of existing content
• Provide feedback to branding and campaign updates actively participating in discussions with agency partners

REQUIREMENTS:

• Minimum of 5 years of professional PowerPoint presentation design experience
• At least 5 years of graphic design experience and some video editing is preferred
• Experience designing for a variety of platforms (web, mobile, print, email, video)
• Prior experience working at a pharmaceutical or biotech is preferred, but not required
• Expertise in designing all kinds of PowerPoint presentations for multiple stakeholders
• Possess strong technical skills in PowerPoint, Word, Photoshop, Illustrator, AdobeXD and InDesign
• Familiar with web technologies and social media platforms and how to design for them
• Proven ability to meet tight deadlines, project manage competing tasks, and work in a team environment
• Highly detail oriented, a strong communicator and can collaborate cross-functionally

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Lead, Commercial Information Strategy will be the primary business owner of Commercial data and reporting and work directly with IT Information Delivery to develop and implement a comprehensive commercial information strategy. This role has business oversight responsibility over Amylyx‘s Commercial Data Environment (CDE), reporting and analytical environments. This role also has responsibility over Amylyx’s data assets in terms of budgeting, contracting, subject matter expertise, quality and quality improvements, and governance in tight coordination with all other Commercial Planning & Operations (CP&O) Leads. This role will report directly into the Head of Commercial Operations & Business Analytics.

Responsibilities

• Responsible for enhancement and oversight of Amylyx’s Commercial reporting environment and function, and building commercial data governance and strategy working closely as the business Lead with IT
• Ensure successful implementation of Commercial Data and reporting roadmap through effective prioritization, stakeholder management, data vendor management, and partnership with other CP&O Leads and Commercial IT colleagues
• Build a Commercial “data excellence” approach to managing all internal and 3 rd party data by managing annual budgeting and contracting process for 3 rd party data sources across all of Commercial
• Serve as subject matter expert to stakeholders on 3 rd party and internal data sources, utilizing experience with data sets in a commercial pharmaceutical environment
• Provide Commercial IT and/or external implementation partners with business requirements regarding the acquisition of new data assets
• Partner with CP&O, IT Information Delivery and/or external implementation partners to design and build dashboard/reporting solutions for various functions within Amylyx’s Commercial organization
• Participate in the design and maintenance of the Commercial data environment, leveraging best practices on reducing complexity, ensuring clear and consistent flow of information across various commercial systems, and establishing policies/procedures as needed
• Partner with IT Information Delivery to design, develop and manage our commercial master data management (MDM) strategies and processes
• Partner with Lead, Commercial Operations & Business Analytics to manage Specialty Pharmacy and Amylyx Care Team (ACT) data vendors as well as 3 rd party data aggregator to improve data quality
• Liaise with CP&O functions regarding commercial data, systems and integrations

Requirements

• • 8-10 years of experience with a bachelor’s degree or 6+ years of experience with a master's degree in a related field of study
  • 7-10 years of progressive experience in Sales Analytics, Advanced Analytics, or Data Management in the pharma/biotech industry
  • Significant experience and knowledge of Biotech and Pharmaceutical data sources and vendors including Komodo, IQVIA/Symphony Health Claims, Prescriber Payer, Prescriber Patient and Source Non-Retail data
  • Previous experience with CRM, MDM, data warehouse and field reporting tools
  • Experience partnering with IT and functional partners to define system and analytical requirements
  • Experience with direct-contract SP and Hub data sources
  • Ability to directly query relational databases and an understanding of database design
  • An understanding of data integration and Master Data Management
  • Familiarity with Business Intelligence tools like Tableau, Qlik Sense etc.
  • Proven track record of effectively collaborating with cross functionally, with multiple stakeholders, including Commercial IT, Sales, Marketing and Market Access in a Biotech / Pharma environment
  • Strong project management skills with the ability to lead process from initiation to implementation
  • Previous technical or consulting experience a plus
  • Excellent verbal and written communication skills required
  • Strong in logical thinking, time management, decision-making, and problem solving, and able to manage multiple programs and priorities simultaneously.
  • Able to operate effectively independently with minimal supervision
  • Ability to oversee and manage external vendors to ensure high quality deliverables

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Lead, Good Pharmacovigilance Practice (GVP) Quality Assurance (QA) oversees the aspects of GVP QA activities internally at Amylyx and supports activities contracted to Contract Research Organization (CRO) and GVP vendors. This role is responsible for leading or providing QA oversight of GVP activities for pre- and post-marketed products. This role is responsible for managing cross functional relationships with internal and external stakeholders.

Responsibilities

• Proactively provide GVP support for clinical and commercial activities to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems
• Partner with Amylyx clinical and commercial stakeholders to drive compliance with pharmacovigilance regulations to maintain alignment with Amylyx systems and standards
• Support development of the SOPs related to GVP activities according to applicable global (ICH) and local standards and regulations
• Lead the development and support the execution of risk-based QA GVP programs
• Support other GxP areas including GMP, GCLP and GCP
• Lead Quality Audit Management for internal and external GVP audits and other GxP areas as needed
• Lead health authority inspection and inspection preparation activities
• Support training GVP activities for business groups, if needed

Requirements

• At least 8 years pharmaceutical or biotechnological drug development experience
• 8+ years GVP quality or compliance related discipline or equivalent quality management activities
• Bachelor’s degree or equivalent professional experience in nursing, pharmacy, medical technology discipline
• Working knowledge of international GxP guidelines (ICH) and directives, international regulatory standards, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA)
• Strong strategic and critical thinking skills
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
• Ability to travel about 20%
• Must be willing and able to be onsite at the Company’s office for employee orientation, meetings, and as otherwise required

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is growing as a global company. We are continuing to build out our Financial, Planning & Analysis team and are seeking a life science industry finance professional that has strong analytical and communication skills to play a critical role in supporting our high growth; a key business partner supporting primarily our General & Administrative functions while providing consolidation and financial reporting assistance to the FP&A team.

RESPONSIBILITIES:

• Act as a financial business partner for the G&A function, provide financial advice and analysis to optimize strategic and operational decisions including planning and analyzing operating expense spending, headcount and capital spending for the function
• Be part of the functional leaderships team(s), understand business needs, have an influencer voice
• Provide monthly value-added management business performance reports
• Strive to enhance and optimize existing processes and implement improvement initiatives
• Partner with the Finance and Accounting teams to deliver business support and analytics, including, but not limited to, monthly and quarterly financial closes
• Lead analysis of financial and operational results and communication of findings to internal stakeholders
• Collaborate with cross-functional teams on company initiatives by providing insightful financial analyses that will support operational efficiency
• Support the Global Head of Financial, Planning and Analysis, and other team members, with consolidation of results across the Company and providing managerial reports to be used by the FP&A team and business users alike
• Support the Company’s planning and budgeting system and process as a super user, acting as the point of contact for the budget owners and the FP&A team

REQUIREMENTS:

• BS in business/finance; MBA preferred
• Minimum 8 years’ relevant experience Strong ERP and Budgeting systems skills, NetSuite and Oracle Planning and Budgeting Cloud Services (PBCS) experience a plus
• Demonstrated success in partnering with accounting and business functions
• Strong analytical skills with expertise in short-term and long-term planning, budgeting and forecasting required
• Biotech/pharmaceutical company experience preferred
• International experience is a plus
• Strong communication and presentation skills a must; ability to present at all levels including senior management

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Responsible for management of the safety/pharmacovigilance safety database and technical systems activities related to clinical and post-marketing use of Amylyx products. Accountable for the successful strategy, oversight, and execution of deliverables for the pharmacovigilance technical systems. This position ensures assessment and implementation of the business needs for all individual adverse event case reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials, medical information, call centers, health authorities, post-marketing commitment studies, etc.) according to Amylyx’s SOPs and global adverse event regulations and guidelines. Ensures appropriate documentation is in place to support activities. Supports aggregate report production and ensures compliance with timely reporting of safety information to Regulatory Authorities in order to meet regulatory requirements.

This role is critical to ensure the PV systems can support the global case processing activities and compliance with regulatory requirements and support global safety surveillance of Amylyx’s products to properly manage the benefit risk profile of Amylyx’s products.

The Role

• Oversees and manages all technical system aspects of drug safety and pharmacovigilance.
• Proactively oversees implementation and continuous improvement of the safety database.
• Accountable for partnering with vendors for resolution of safety technical issues and questions, identifying vendor training needs and opportunities for improvement and ensuring implementation in collaboration with Amylyx stakeholders.
• Accountable for effective oversight of outsourced safety-related technical activities according to Amylyx standards and contracted Service Level Agreements(s).
• Provide direction and leadership regarding the safety database and related technical PV systems.
• Assist in management of all critical departmental timelines and budgets when applicable.
• Ensure appropriate documentation by identifying and preparing required written procedures.
• Provide technical systems input into PV SOPs and review SOPs from other functions.
• As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and (clinical) team meetings.
• Identify opportunities for process efficiencies and participate in process improvement initiatives.
• Ensure compliance with FDA regulations and International Conference on Harmonisation (ICH) guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.

The Requirements

• Bachelor’s degree in nursing or information technology preferred.
• Minimum 8 years of pharmaceutical experience with a demonstrated focus in PV operations and safety databases.
• Experience with safety database migration, validation, and implementation.
• Experience with validated drug safety databases (preferably Veeva Vault Safety, ARGUS, Arisg, etc.) WHO Drug, and MedDRA.
• Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
• Working knowledge and experience with European pharmacovigilance regulations required.
• Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review and regulatory submission, issuing follow up queries, etc.
• Demonstrated technical, administrative, and project management capabilities.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Adaptable to changing priorities.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within the company.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals in alignment with corporate goals.
• Proficient computer skills, including Microsoft Word, PowerPoint and Excel.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Responsible for alliance management activities related to clinical and post-marketing use of Amylyx products. Provide stewardship over contracts and relationships with external partners and vendors. Provides insight and accountability for successful strategy, oversight, and execution of deliverables related to those agreements. Ensures proper documentation is in place to support activities and ensures corrective or preventative actions when applicable.

This role is critical to ensure the PV systems can support the global case processing activities, compliance with regulatory requirements, and support global safety surveillance of Amylyx’s products to properly manage the benefit risk profile of Amylyx’s products.

The Role

• Develop policies, processes and procedures regarding outsourcing strategies, implementation plans, and operational activities in support of better PV vendor and licensing/business partner alliance management.
• Participate as the PV representative in internal and external meetings related to partner alliances and cross-program global operations as required. Responsible for the establishment of Safety Data Exchange Agreements (SDEAs)/Pharmacovigilance Agreements (PVAs) within contractual relationships and manage these alliances directly and via support staff. Negotiation and oversight of Pharmacovigilance Agreements with Amylyx business partners and vendors.
• Responsible for interactions with global vendors and partners for rapid/proactive identification and resolution of PV-related questions and issues. Escalate issues within PV alliances to management as appropriate.
• Accountable for partnering with and managing vendors for resolution of safety operational issues and questions, identifying vendor training needs and opportunities for improvement and ensuring compliance in collaboration with Amylyx stakeholders.
• Responsible and accountablefor effective oversight of outsourced operational activities, measuring vendor performance through Key Performance Indicators/Metrics according to Amylyx standards and contracted Service Level Agreements(s).
• Coordinates the management of safety data exchange agreements (SDEA), safety management plans (SMP), and other operating procedures with business partners as required.
• Provide direction and leadership regarding the PV alliance processes and procedures.
• Ensure appropriate documentation by identifying and preparing required written procedures.
• Provide technical systems input into PV SOPs and review SOPs from other functions.
• As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and (clinical) team meetings.
• Identify opportunities for process efficiencies and participate in process improvement initiatives

The Requirements

• Bachelor’s degree in the life sciences or related area, master’s degree or higher preferred
• Minimum 8 years of pharmaceutical experience with a demonstrated focus in PV operations and alliance management.
• Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
• Working knowledge of validated safety databases (preferably Veeva Safety or Argus)
• Working knowledge and experience with European pharmacovigilance regulations required.
• Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review, and regulatory submission, issuing follow up queries, etc.
• Demonstrated technical, administrative, and project management capabilities.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Adaptable to changing priorities.
• Skilled at negotiating with vendors, business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Amylyx.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals in alignment with corporate goals.
• Proficient computer skills, including Microsoft Word, PowerPoint, and Excel

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Sr. Specialist, Quality Management Systems will be a creative, resourceful, and critical thinker who will primarily be responsible for managing the lifecycle of product quality complaints (PQCs) and annual product quality reviews (APQRs) in the electronic quality management system (eQMS). This individual will work on assignments that are complex in nature where judgment is required in mitigating risks, identifying opportunities for improvement, and making recommendations. The individual will support inspection readiness activities to assure Amylyx is prepared to host inspections at all times.

The Role

• Perform intake of PQCs and manage PQC records in the eQMS until closure.
• Perform periodic reconciliation of PQCs and prepare reconciliation reports.
• Manage annual product quality review (APQR) compilation, review, and reporting.
• Write and revise standard operating procedures (SOPs) and work instructions (WIs) to support continuous improvement of the PQC and APQR processes.
• Provide support during internal and external audits and Health Authority inspections.
• Keep abreast of the requirements for compliance and participate in required training on regulatory issues affecting own area of work. Notify management of regulatory compliance questions, concerns, and issues.
• Monitor and analyze metrics. Prepare periodic reports reflecting the overall health of the PQC and APQR processes and present data to senior/executive management teams as required.
• May perform duties related to other eQMS activities, such as deviations, CAPA, continuous improvements, risk management, and change controls.

The Requirement

• Associate’s Degree, or equivalent years of experience
• 5+ years of biotechnology/pharmaceutical industry experience in Quality or similar GxP compliance role
• 2+ years of experience leading teams/projects
• Knowledge of appropriate regulatory requirements, including EU, Canada and FDA GxP requirements as applicable to clinical trials, manufacturing, testing, packaging, and distribution.
• Experience in preparing for and supporting inspections by regulatory agencies.
• Ability to effectively prioritize and manage multiple projects and tasks in a fast-paced environment.
• Outstanding communication skills (verbal and written)
• Ability to travel about 10%.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Senior Clinical Data Manager provides study-level oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming. The Senior Clinical Data Manager is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the primary Data Management (DM) representative to the study management team.
Responsibilities

• Provide study-level oversight of clinical data management activities, monitors and reports on overall study progress
• Develops project timeline and monitors data deliverables for all assigned studies in collaboration with cross functional team members and vendors
• Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans – identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF).
• Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
• Develops risk mitigation or action plans and oversees execution when appropriate
• Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.
• Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) and external customers (CROs, external data vendors, etc.).
• Oversee the performance and quality issues with vendors and escalates to management and develops appropriate risk mitigation as neede

Requirements

• Bachelor’s degree or higher in Life Science or related discipline
• 8 years of clinical data management experience, previous work with CROs and Data Management vendors is required
• Knowledge of FDA & ICH/GCP regulations and guidelines
• Strong knowledge with medical dictionary coding standards, GCP, 21 CFR Part 11, Clinical Data Management best practices
• Excellent interpersonal, communication, and organizational skills with the ability work cross-functionally and as part of a team
• Ability to build relationships and manage expectations with CROs/external vendors
• Experience with eTMFs pertaining to CDM documentation

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

In this newly created position will lead the global purchase of goods and services for Amylyx. The successful candidate will develop and manage the global purchase order process with business owners. You will also be a critical team member who will optimize the global procurement process to enable Amylyx’s continued growth in a scalable and sustainable manner.

Responsibilities

• Develop and lead the purchasing process including the timely review of Purchase Requisitions/Purchase Orders for completeness, accuracy and appropriate approvals, designated vendor sources, and other purchasing related activities as required.
• Subject matter expert coordinating discussions with other functions with process or system integration requirements or adjacencies to Procurement.
• Lead and support the business stakeholders through the purchasing process.
• Leverage spend analytics to identify consolidation opportunities, understand total cost of ownership, and rationalize opportunities.
• Building, implementation and enforcement of purchasing SOPs and adherence to Sarbanes-Oxley Controls involving Procurement.
• Deliver NetSuite training on purchasing processes and ensure adherence to company policies relative to procurement.
• Manage Master Data within NetSuite, support supplier qualification & onboarding, risk mitigation & performance management and partner with AP to resolve any gaps.
• Develops sources of supply and services and obtains information from suppliers/contractors concerning product and/or services specifications, price, delivery, dates, etc.
• Solicits proposals, conducts quick bids as directed.
• Negotiate materials, equipment and supplies from suppliers & contractors along with general company accepted terms and issue purchase orders as directed bid events, to ensure best pricing, as per company approval policy. Support the identification of new qualified sources where appropriate.
• Work closely with Accounts Payable and internal business partners to promptly resolve supplier payment issues, dispute resolutions and corrective action plans.
• Drive process improvement and continuous improvement in all aspects of assigned job duties
• Other ad hoc analyses/special projects as required.

Requirements

• Bachelors degree
• Minimum 15 years’ procurement experience in a global publicly traded company
• 7+ years managing a team in a public company setting
• Prior experience working in or supporting growing pharmaceutical, medical device or other GxP-governed biotech organizations
• Working knowledge of purchasing, modern procurement processes and practices, and the ethics of the supplier / purchaser relationship
• Strong attention to detail, decision-making, time management and organizational skills.
• Strong project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation.
• Solid analytical skills and solution-driven thinking; collects and researches data; uses intuition and experience to complement data.
• Demonstrated communication and teamwork capabilities and the ability to work well across the organization.
• Proficient in Microsoft Office Suite of applications.
• Experience working with mid-size to large ERP systems, NetSuite a plus

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

In this newly created position, you will assist the Head, Accounting & Financial Operations in overseeing and assisting with all areas of intercompany accounting, including month-end close process & calculations, intercompany process/coordination with subsidiaries and tax compliance support. We look forward to welcoming new talent to our fast-paced and team-oriented environment, where you will demonstrate sound judgement, give strong attention to detail and be motivated to learn and take on additional responsibility without jeopardizing quality of existing responsibilities.

You must bring with you, public company global intercompany experience running a quarter-end close process to meet filing deadlines and be familiar with implementing and ensuring compliance with SOX controls. Additionally, you will be capable of building, implementing, and maintaining policies and procedures, and be able to provide support to other members of the finance team during the month end close process.

RESPONSIBILITIES:

• Lead and oversee the intercompany month end close process.
• Prepare and/or review monthly intercompany journal entries, balance sheet reconciliations, and flux analysis ensuring adequate documentation support is prepared and maintained.
• Establish, monitor and enforce polices around intercompany, eliminations, settlements, revaluations and consolidations and understand foreign exchange reporting.
• Support SOX compliance efforts for specific areas of responsibility, implement best practices and internal controls.
• Develop, implement, enforce and maintain system policies and procedures to ensure efficient and compliant processes.
• Coordinate with external auditors on quarterly reviews and year-end audit.
• Support tax compliance activities.
• Accomplishes objectives by managing staff and planning and evaluating activities.
• Recruit, select, train and evaluate direct report(s) to enhance their performance. Ensure direct reports including contractors are effectively motivated.
• Communicate job expectations; plan, monitor, and appraise job results.
• Maintains and enforces quality and customer service standards, analyzes and resolves quality and customer service problems.
• Evaluate on-going opportunities for process/system improvement and develop reporting and analytics as needed

Minimum Requirements

• Bachelor’s degree in accounting, Finance or Business
• Minimum 8 years of combined public accounting and public biotechnology/pharmaceutical industry accounting experience
• Prior experience working in intercompany accounting directly overseeing 20+ subsidiaries.
• 3-4 years of supervisory experience.
• CPA

Preferred Qualifications

• Big 4 public accounting firm experience
• Experience in the corporate accounting department of a publicly traded global commercial life sciences organization
• Experience working with mid-size to large ERP systems, NetSuite experience a plus.
• Strong attention to detail, decision-making, time management and organizational skills.
• Strong interpersonal, communication, analytical and problem-solving skills.
• High professional and ethical standards for handling confidential information.
• Excellent interpersonal skills required (team player / ability to work cross functionally).
• Self-motivated, ability to work independently and collaboratively.
• Ability to navigate and be successful in a fast-paced, dynamic work environment.
• Proficient in Microsoft Office Suite of applications.
• Superior customer service skills.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

National Clinical Specialist (CS) Lead is responsible for the education of Nurses (RNs, BSNs) and office staff within ALSA centers of excellence. Education will be focused on the clinical benefits of Relyvrio, ALS disease state, and access best practices. The Clinical Specialist will partner with RBDs and KAMs to determine educational focus with HCPs utilizing their knowledge of multidisciplinary care and the process of utilizing therapeutic interventions in ALS to have clinical conversations with APPs (PAs and NPs) discussing Relyvrio within label.

The role requires a high level of collaboration with the Commercial Team which includes: RBDs, KAMs, Marketing, Thought Leader Liaisons, Operations, Market Access, Human Resources, ACT, Legal, Medical, Compliance and Regulatory.

Responsibilities

• Educate ALS specialists Nurses (RNs, BSNs) and office staff, Advanced Practice Practitioners (PAs, NPs) and Clinicians on clinical data regarding disease, diagnostics, and treatment with a focus on features and clinical benefits of Relyvrio
• Support Field Teams on key initiatives for patient identification, adherence, and treatment
• Partner with Medical and Marketing to work with advocacy groups to provide education to Care Coordinators and other advocacy care team members. Education may include, but is not limited to, ALS disease state, Relyvrio clinical benefits and setting appropriate expectations for people living with ALS. as requested by Care Coordinators regarding ALS disease and treatment with Relyvrio setting expectations within label
• Share clinical expertise as a Clinician who has diagnosed, treated and understands the challenges of ALS as well as how a multidisciplinary Care Team operates.
• Assist with the development of marketing materials specific to account staff who manage the process at multidisciplinary centers
• Development of the regional clinical specialist model for the Commercial Sales Team by delivering training on disease, diagnosis, and treatment in conjunction with Training and Medical Team
• National Nurse advocate – develop marketing materials geared towards clinic nurses with a focus on clinical efficacy and adherence
• Partner with marketing to develop novel approaches to engage clinicians, NPs/PAs and RNs. Work with key opinion leaders to develop consensus statements/case studies and promotional white papers
• Partner with ACT to develop patient focused promotional materials

Requirements

• BA/BS Degree required, BSN, MSN, APRN preferred
• Minimum 5 years in patient care with knowledge of neuro degenerative disease preferred
• Experience in rare disease areas is a plus
• Exceptional platform skills (virtual as well as live) as well as written and verbal communication skills
• Strong understanding of current legal and regulatory requirements related to Training
• Requires proficiency in Microsoft Office Suite (Outlook, PowerPoint, Word, Excel) business writing skills
• 75% travel

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

This position can be hybrid or remote. Our offices are in Cambridge, MA.

Amylyx is seeking a highly motivated, experienced, and detail-oriented individual to join our fast-paced team as a Lead, Technical Accounting and External Reporting. As part of the finance and accounting team, you will be a key member in the preparation of the company’s financial statements and will provide valuable input and guidance to ensure that all activities are recorded and reported in accordance with US GAAP and internal accounting policies. You will conduct research to advise on the financial reporting implications of new and amended agreements and accounting standards, formulate position papers, assist with SOX compliance, and play a significant role in shaping the accounting policies and processes of a growing organization. This is a hands-on position and the ability to multitask and work cross functionally is essential. This role reports to the Head, Technical Accounting and External Reporting. If you are looking for a high-impact role in a rapidly growing and changing organization, then this role could be a great fit for you!

RESPONSIBILITIES:

• Assist in the preparation of the company’s external financial reports, including SEC reporting (Form 10-K’s, Form 10-Q’s, Proxy, etc.) and the XBRL process, as well as earnings releases
• Help ensure compliance with all U.S. GAAP and related SEC financial disclosure requirements
• Assist with the planning and execution of SOX testing, documentation, and compliance
• Prepare recurring and non-recurring journal entries related to financial reporting
• Prepare account reconciliations
• Evaluate and analyze emerging accounting and reporting standards from the FASB, SEC and other standard setters
• Assist in the development and implementation of new accounting policies and processes for a rapidly growing organization
• Review material contracts to determine proper accounting treatment and draft technical memos for various accounting matters as needed
• Review purchase orders to ensure proper P&L classification
• Support the annual audit and quarterly review activities with external auditors
• Identify areas for process improvements and opportunities for efficiencies, without compromising quality
• Assist with other ad-hoc projects, such as developing processes related to revenue and inventory, performing research and leading implementation of new accounting standards

REQUIREMENTS:

• Bachelor’s degree in Accounting, Finance or Business
• Minimum of 8 years of experience in public accounting, or a public/industry accounting mix, with associated technical accounting and public company reporting experience
• CPA is required
• Strong understanding of accounting principles, including US GAAP, SEC reporting, and SOX compliance
• Ability to work independently and in a team environment
• Ability to collaborate with cross-functional teams to implement new accounting standards and policies
• Strong interpersonal, verbal, and written communication skills
• Deeply committed to accuracy and pride in attention to detail
• Strong decision-making, time management and organizational skills
• Proficient in Microsoft Office Suite of applications
• Self-starter with the demonstrated ability to work in a fast-paced atmosphere and ability to problem solve with minimal supervision

PREFERRED QUALIFICATIONS:

• Experience with financial reporting software such as ActiveDisclosure
• Experience with ERP systems; NetSuite preferred

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Lead of global Scientific Insights and Education will collaborate across the global Medical Affairs team to develop innovative and engaging content informed by the latest science, data, and insights. Reporting to the Head, Medical Strategy and Communications and working collaboratively and cross-functionally, the role will provide critical scientific and medical support to the Field Medical, global Medical Affairs, and Clinical Development teams in addition to gathering and disseminating important scientific updates and insights to the broader cross-functional team. This role is uniquely positioned to identify scientific and medical gaps and needs through insight gathering and to then develop tools and multichannel content for use both internally and externally.

This is a remote based position; the individual can live in the US, Europe, or Canada.

Responsibilities

• Collaborate with global Head of Medical Strategy and Communications, Head of Global Medical Affairs Operations, and regional Heads of Medical Affairs (i.e., Canada, US, EMEA) on the scientific training strategy, planning, and certification process for new hires and ongoing training needs
• Drive the development and updating of scientific and medical educational materials (e.g., Power Point slides, Word documents and other formats) for internal training and proactive/reactive external use related to ALS and pipeline indications in collaboration with the global Heads of Medical Strategy and Communications, and Medical Affairs Operations, and regional Heads of Field Medical Affairs
• Support the development of scientific materials for Medical Affairs & Clinical Development activities at all congresses — including booth content, display materials, and handouts
• Create and execute annual Global Medical Affairs training plan taking into account anticipated data readouts, abstracts, presentations, and scientific community advances
• Liaise with and manage external vendor(s) as needed to develop/update materials with a high degree of medical / scientific accuracy, functional usability, and on time and on budget. Facilitate and coordinate review and approval of materials via either functional and/or MLR review
• Determine agenda and lead monthly internal field medical training and insight calls during which training is provided, new materials are reviewed and launched, and field team insights are shared
• Attend scientific conferences and provide medical and scientific intelligence coverage for sessions, posters, and satellite events
• Gather, collate, and interpret medical and scientific insights from scientific conferences, publications, anticipated trial read-outs, and company announcements. Summarize findings and provide strategic recommendations in the form of monthly medical intelligence and publication updates as well as event-specific (conferences, major announcements) summaries
• In collaboration with Global Medical Affairs and Market Insights, lead the identification of key gaps in insight sharing across the Company and identify potential solutions, including global tools, to help fill these gaps and have a coordinated and comprehensive accounting of knowledge gathered and insights generate

Requirements

• Doctorate Degree (MD/DO, PharmD, Ph.D.)
• Minimum 8 years of pharmaceutical and/or agency experience in content development, training, or medical insights
• Demonstrated strength in medical strategy development as well as the ability to analyze research design, methods, and outcome measures critically
• Communicates clearly, concisely, and is easily understood in written materials and presentations
• Preferred experience/knowledge of the CNS therapeutic area and/or training in neurology, psychiatry, neuroscience, or neurophysiology
• Flexibility to travel 20% of the time, including international travel

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx’s Global Compliance function is responsible for developing, implementing, and monitoring the operation of the Company’s healthcare Compliance Program, including Compliance policies, training, auditing and monitoring, reporting, investigations, and remediation. The Head, Global Compliance Operations and Business Partnering, will report to the Head, Deputy General Counsel & Global Compliance Officer, and will serve as a collaborative partner to the business and play a key role in evolving the Compliance function at a newly commercialized and globally expanding company.

RESPONSIBILITIES:

• With Global Compliance Officer, developing and implementing Compliance program strategy, including Compliance communications strategy to foster a values-based culture.
• Developing and delivering practical training and serving as go-to point of contact to the business.
• Leading fit-for-purpose adaptation of Compliance program for globally expanding company, including in EMEA, APAC, and LATAM.
• Leading improvement of Compliance operations (e.g., fair market value analyses, and grants and sponsorship review and approval processes).
• Independently managing outside counsel and/or compliance consulting external resources.
• Designing, managing, and overseeing compliance with U.S. (state and federal) and global transparency reporting requirements.
• Leading growth of the company’s anti-bribery and anti-corruption program, including through auditing and monitoring and third-party risk management.
• Developing and implementing auditing and monitoring plans, and conducting auditing and monitoring activities and reporting.
• Assisting with Enterprise Risk Management program, including monitoring of controls and mitigations progress.
• Independently conducting compliance investigations and remediation.

Requirements

• Bachelor’s degree; and Juris Doctor, Masters and/or Compliance certification, or substantial experience at compliance consulting or accounting firm.
• 15+ years of healthcare compliance experience with a focus on the biotechnology/pharmaceutical industry.
• Desire to both lead on strategic matters and “roll up sleeves” to implement day-to-day Compliance operations.
• Excellent leadership and interpersonal skills and ability to thrive in fast-paced environment.
• Excellent analytical and problem-solving skills.
• Experience independently conducting investigations on sensitive matters.
• Auditing and monitoring and compliance operations experience, including demonstrated ability to identify areas for improvement in controls, systems, and processes.
• Excellent project management skills with the ability to manage multiple priorities simultaneously and drive execution.
• Strong oral and written communication and presentation skills, and professionalism to handle sensitive matters confidentiality and with discretion.
• Demonstrated commitment to compliance, ethics, and accountability.
• Ability to travel approximately 15-20% of time.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

As a Lead IT Business Partner at Amylyx Pharmaceuticals, you will deliver and support IT-related initiatives and lead system implementations with accompanying components. In this role you will directly interface with our commercial and communication teams including corporate communications, marketing, legal, commercial operations, field sales, and payer access.

To ensure Amylyx has a stable, robust, and scalable set of applications to support our growing business needs, it is imperative that our Lead IT Business Partner align cross functionally with other business partners. This position will encompass many activities including: evaluating new functionality while maintaining the integrity of applications; partnering with other groups across the IT team, delivering on the business goals, refining existing solutions, and prioritizing the day-to-day of existing solutions. This critical role is highly visible and responsible for supporting multiple business groups.

Primary Responsibilities

• Successfully implement and support Amylyx systems leveraging appropriate platforms.
• Elicit, document, and execute on the overall systems strategy for business partners.
• Oversee enhancements to all technology components used by supported groups within organization.
• Support change management and governance activities by partnering with key business users to ensure new items are tested and implemented to meet the business needs.
• Oversee test script creation, user testing and user documentation for systems.
• Ensure appropriate IT processes, procedures, and standards are developed, monitored and are in place.
• Introduce best practice and process improvement ideas where appropriate.
• Occasionally manage projects using project management best practices.
• Serve as the conduit between the customer community (internal and external customers) and the various services teams.
• Elicit requirements using interviews and workshops, document analysis and business process descriptions, use cases, scenarios, business analysis, task, and workflow analysis.
• Develop and foster effective relationships between the business, partners, and IT.
• Manage external partners regarding applications and enhancements in line with the overall company objectives and solution capabilities.
• Coordinate issue resolution with internal and external support providers.
• Work with other IT team members to maintain roadmap for the integration of solutions with Veeva, Salesforce, and other SaaS solutions (e.g., data warehouse and analytical platforms).
• Develop ad hoc reports using the tools available within the applications based on input from the business.
• Lead small-group training sessions as needed.
• Ability to learn new applications and functionality as additional needs arise.
• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• Other duties as assigned.

Requirements

• Bachelor's degree in computer science or related field strongly preferred.
• A minimum of 8 years of IT experience with progressively increasing technical and support responsibilities.
• Minimum of 3 years of experience in working with Salesforce.com, Veeva products, and/or other SaaS platforms.
• Minimum of 3 years of experience supporting / working with a patient call center (or equivalent).
• Experience supporting applications within the pharmaceutical/biotech industry (or equivalent).
• Experience in interpreting the applicability of local and federal laws/regulations (including data privacy practices and laws) to company operations.
• Demonstrated ability to manage several complex deliverables at the same time.
• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of executives, managers, and subject matter experts.
• Strong customer service orientation.
• Ability to multitask – effectively manage work requests across multiple business areas.
• Highly self-motivated and directed.
• Ability to initiate, persuade, and influence others on the best solutions to action.
• A strong drive to work on projects with minimum supervision while adding value to cross-functional teams and achieving goals.
• Strong analytical skills required including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.
• Knowledge of FDA regulations, GDPR, SOX and/or HIPPA compliance is a plus.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is seeking a highly motivated, experienced, and detail-oriented individual to join our fast-paced team as a Lead, Revenue Accounting. As part of the finance and accounting team, you will be a key member in preparing the company’s revenue reporting that will be used internally and as a part of our quarterly external reporting. You will also be a part of preparing and reviewing our government price reporting requirements. This role will require collaboration with our Commercial, Market Access, and Data Analytics teams and external consultants. This role reports to the Head Revenue Accounting. If you are looking for a high-impact role in a rapidly growing and changing organization, this role could be a great fit for you!

Responsibilities

• Prepare gross-to-net accounting estimates/accruals, including applying appropriate methodologies and calculations on gross-to-net inputs ensuring compliance with accounting standards (GAAP) and controls.
• Monitor accrual assumptions underlying the GTN revenue accounting for monthly and quarterly revenue in coordination.
• Prepare journal entries, month-end accruals, and reconciliations for completeness and ensure proper documentation to support required management review
• Manage the data prep, validation, calculation, and analytics related to participation in the following government programs:
• VA Federal Supply Schedule Program
• Medicaid Drug Rebate Program
• PHS 340B Drug Discount Program
• TriCare Retail Refund Pricing Agreement
• Review the calculation of one or more of the following: Average Manufacture Price (AMP), Best Price (BP), non-Federal Average Manufacturer Price (nFAMP) and Federal Ceiling Price (FCP).
• Partner with third-party vendors to submit all approved government pricing calculations to the appropriate government agencies within the statutory reporting deadlines.
• Communicate to 3PL, distributors, and other relevant external trading partners the annual FSS price and quarterly 340B price.

Requirements

• Bachelor’s degree in Accounting, Finance, or Business
• Minimum of 8 years of experience in biotech/pharmaceutical companies or Big 4 accounting experience.
• Strong understanding of Gross to net components and government pricing policy
• Ability to work independently and in a team environment
• Ability to collaborate with cross-functional teams and implement process improvements as necessary
• Strong interpersonal, verbal, and written communication skills
• Deeply committed to accuracy and pride in attention to detail
• Strong decision-making, time management, and organizational skills
• Proficient in Microsoft Office Suite of applications
• Self-starter with the demonstrated ability to work in a fast-paced atmosphere and ability to problem solve with minimal supervision
• Ability to manage multiple projects

Preferred Qualifications

• Experience with ERP systems; NetSuite preferred

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

As a key member of our growing Supply Chain organization, the Product Labeling Designer, GXP is responsible for creation of clinical and commercial labeling. Reporting to the Lead, Global Artwork, you will provide development and operational execution of activities required to design and approve clinical and commercial labeling for Amylyx drug products.

Responsibilities

• Supports and is responsible for processes for the design, development, and implementation of clinical and commercial labeling.
• Collaborates and coordinates across applicable Amylyx functional areas (Regulatory, Legal, Commercial, Medical Affairs, Supply Chain, Quality Assurance) on design, development, and approval of packaging component content (text, graphics, data).
• Works with outside contractors and CMOs to finalize and approve artwork, die-lines, proofs, and associated documentation.
• Collaborates with packaging CMOs to coordinate and complete design and development, and approval, of packaging component specifications.
• Monitors and manages all systems and transactions associated with responsibilities, including internal Amylyx EDM and associated CMO and contractor systems.
• Manages applicable Change Control documents for packaging component-related activities.
• Assists in the development and implements appropriate systems and processes for completion of required translation services for applicable packaging components. Ensures that component layouts accommodate required text and graphics.
• Responsible for the administration of product serialization, including master data creation and approval, GTIN number and associated documentation, and processes involved in product serialization.

Requirements

• Bachelor’s degree in graphic arts; advanced degree in a related discipline a plus.
• 5+ years in direct graphics development (or equivalent role) with at least 2 years design experience in product labeling.
• Understanding of pharmaceutical-related clinical and commercial packaging and labeling GMP requirements, regulations, and guidelines.
• Working knowledge of graphical design concepts and global pharmaceutical product labeling and packaging component development processes.
• Experience managing artwork development for pharmaceutical products.
• Experience in collaborating and managing external partners (packaging CMOs, contractors/consultants) in the design and development of packaging components.
• Working knowledge of the EU Falsified Medicines Directive (FMD) and similar anti-counterfeiting regulations and requirements is a plus.
• Strong organizational skills.
• Advanced knowledge working with Adobe InDesign & Illustrator.
• Product launch experience a significant plus.
• Possible travel (<10%) required.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

In this role you will be a hands-on leader reporting directly to the Chief Technical Operations Officer. You will be accountable for developing the external supplier network for the company leveraging a balance of strategic, tactical, and operational plans and processes to support the Company’s clinical and commercial programs. The ideal candidate will be an experienced leader who is familiar with virtual operations through contract development and manufacturing organizations (CDMO’s) ensuring supply continuity for Amylyx requirements.

Responsibilities

• Lead the CDMO selection process in collaboration with internal stakeholders, including developing and negotiating development, technology transfer, and manufacturing/supply contracts.
• Manage the existing CMO/CDMOs and Packaging partners.
• Establish governance structures (joint project teams, steering committee) that facilitate timely, open communication with CDMOs and internal stakeholders, and successful delivery of CDMO services.
• Oversee and lead interactions with external manufacturing partners to assure on-time quality supply which meets compliance and regulatory requirements.
• Assist in alliance development and management as needed.
• Establish and manage the necessary manufacturing agreements including MSA’s (Master Services Agreements).
• In partnership with the Quality organization, manage and ensure the timely review and release of product from external manufacturing partners.
• In partnership with the Regulatory function, manage the process improvements, continuous monitoring and validation and implement and product life cycle management changes per established time commitments.
• In partnership with Commercial function, manage the demand and supply.
• Author and/or approve technical reports, manufacturing instructions, process validation documents, regulatory submissions and other technical and management documents as needed.
• Manage overall External Manufacturing and Supply Chain budget and spending, carefully balancing risk and cost.
• Provide leadership for commercial & clinical supply continuity and risk management processes, including ownership of supply chain plans, inventory and forecasts used to support Amylyx programs.
• Lead the evaluation of Supply Chain redundancy efforts and programs continuously evaluating the risk of supply partners and operations making necessary recommendations and implementation plans to reduce potential interruptions to supply operations.
• Hire, lead, and develop employees to successfully meet group objectives.

Requirements

• 15+ years of outsourced clinical and commercial manufacturing and supply chain management experience in the biotech/pharmaceutical industry.
• Experience in managing outsourced manufacturing and supply chain.
• Track record of developing, negotiating, and administering clinical and/or commercial contract manufacturing agreements.
• Strong knowledge and experience in designing and implementing outsourced manufacturing and supply chain best practices.
• Deep familiarity in phase-appropriate cGMP quality systems with good understanding of regulatory requirements.
• Firsthand experience in authoring and reviewing regulatory documents and participation in regulatory audits from agencies like FDA, EMA, PMDA, etc.
• Experience with manufacturing technical support or manufacturing sciences and technical support organization.
• Experience in handling and leading investigations, deviations, and quality events.
• Prior participation in CAPA, developing CAPA plans, audit reports, annual reports, validation plans, protocols, assessments, technical memo and other regulatory and quality documents etc.
• Experience and comfort level with operating in early-stage pharma/biotech environment
• Intercultural experience and ability to operate and adapt in a complex and rapidly changing business environment.
• Impeccable problem solving and collaboration skills with quality-driven mindset.
• Proven ability to facilitate conversations and drive towards decisions. Ability to influence.
• Proven ability to lead teams and develop individuals.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Amylyx is seeking an experienced, real-world evidence (RWE) expert who will lead the l development of the real-world evidence plan and its execution to support Relyvrio/Albrioza value proposition across the globe. Reporting to the Head of Global HEOR, you will lead the cross functional team comprised of members from: Clinical Development, Medical Affairs, Market Access and Commercial.

As a leader of the matrix team, you develop the RWE strategy that will be part of a broader integrated data generation plan and will comprise external collaborations and internal research projects. As needed, you will also conduct RWE advisory boards and be responsible for the timely dissemination of RWE projects, in alignment with the company’s broader scientific communication strategy.

Responsibilities

Cross-functional collaboration:

• Ensure cross-functional collaboration with clinical development, medical affairs, market access, commercial and other key partners to ensure development and effective execution of RWE strategy as a part of an integrated evidence generation plan.
• Lead alignment of RWE planning and execution with the global commercial/medical leadership to ensure alignment with strategic imperatives as well as consistency and harmonization of messaging, strategy, tactics, and communication.
• Collaborate with regional- and local-level Market Access colleagues to ensure appropriate and effective use of RWE for achieving and maintaining optimal patient access.
• Collaborate with field medical team to ensure integration of medical insights into RWE planning, execution as well as dissemination.
• Ensure consistency and synchronization with clinical development initiatives for future assets--includes registrational and non-registrational RWE-based data needs (e.g. historical control cohort, relative effectiveness research etc.).
• Collaborates cross functionally to design initiatives that incorporate diversity considerations into all activities considering health disparities, health literacy, and pertinent access considerations.

Strategy:

• Develop long-term global (North America and Big-5 EU focus) RWE strategy (3-5 years’ time-horizon) with emphasis on short-term as well as long-term deliverables.
• Develop a comprehensive external and internal RWE as well as ALS thought-leadership engagement plan for executing RWE Book of Work (BoW).
• Ensure integration of patient and advocacy perspective in development and execution of RWE strategy.
• Collaborate with North America/Big-5 EU (regional) colleagues during annual strategic planning process.
• Ensure integration of regulatory considerations in developing RWE data consistent with label as well as potential label expansion.

Execution:

• Ensure alignment with RWE best practices as promoted by ISPOR, ISPE and other relevant organizations.
• Develop comprehensive short-term and long-term budget plan for RWE BoW.
• Efficient and on-target deployment of resources to execute the RWE strategy (+/-15% variance at mid-year and +/- 5% variance at year-end).
• Adherence to the ISPOR/ISPE RWE guidelines for scientific execution of RWE protocols.
• Ensure flawless alignment with scientific communication strategy and goals and dissemination plans for key congresses/meetings.
• Timely dissemination of RWE findings consistent with ICJME guidelines and Amylyx policies.
• Efficient management of external vendors involved with planning, execution and dissemination of RWE studies.

Requirements

• MD, PhD or PharmD with 3+ years RWE experience, OR Master’s degree with 8+ years RWE experience.
• Prior strong experience in biopharma implementing or overseeing a wide variety of observational/prospective studies; disease or product registry experience preferred.
• Expertise in at least one of Amylyx’ target areas (neuroscience or rare diseases).
• Deep scientific expertise in key scientific fields related to real world evidence (e.g. epidemiology, statistics etc.)
• Strong strategic thinking skills, as evidenced by the ability to identify alternative scenarios, resulting implications, and development of pragmatic recommendations for direction or action.
• Ability to propose, defend and manage RWE budgets consistent with broader evidence strategy. As well as manage RWE budgets that may include: external grants, external vendor support, data acquisition and management costs, data analytics and data reporting/dissemination.
• Able to review, evaluate, interpret and present complex data; understand the emerging safety and efficacy profile of pharmaceutical products.
• Strong publication record in peer-reviewed journals and/or congresses.
• Experience in supporting development phase as well as launch-phase assets is preferred.
• Strong understanding of payer environment in the US and/or Europe, including CMS policy commercial payers as well as Medicare, health technologies assessment, and health policy and ability to tailor strategies to a diverse set of payer archetypes.
• Demonstrated ability to work in a cross-functional environment to develop and execute projects.
• Strong work ethic, and proven track record of delivering high quality within timelines.
• Strong written and verbal communication influencing skills to address leadership and external audiences.
• Strong project management and prioritization skills to effectively manage and drive multiple projects and initiatives in a fast-paced environment.
• Ability to travel (25%) domestically and on occasion, internationally.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Lead, Canada ALS Marketing is a critical member of the Amylyx Canadian team. Responsible for development of engagement strategies based on insights and in partnership with cross-functional stakeholders. The position owns development and operationalization of the Canada strategy for Marketing, which ensures the organization is equipped to meet and exceed objectives.

Reporting to the Head, Canada Sales, Marketing & Commercial Operations this role will lead all marketing related initiatives for Canada. It also requires the ability to collaborate cross functionally and contribute to projects across the organization in Canada and the US. This position leverages insights learned in collaboration with market insights, medical, global marketing, and field-based teams to drive strategic plans and execution in country.

The Role

• Brand leader in Canada responsible for ensuring the effective workings of the cross functional brand team and work closely with Medical to ensure seamless yet compliant in-field execution in Canada
• Understand the ALS community in Canada
• Lead the annual strategic planning process in Canada
• Key input into annual Canada target setting process
• Support Canada’s ongoing commercialization efforts by collaborating and sharing US content to enable an effective and efficient Canadian trajectory
• Continuously drive innovation by understanding industry trends, seeking out HCP engagement tools, and introducing new vendors
• Critically evaluate the effectiveness of programs through KPIs and other metrics to ensure positive return on investment and achievement of objectives
• Plan for and track spend against yearly budget. Accountable for successful completion of projects on time and on budget
• Work closely with all teams to shape field strategy, gather insights, and provide input
• Work seamlessly with leadership to ensure high performing field teams
• Provide feedback to Global team with “lessons learned” as we continue to support the ALS community
• Develop message architecture and core assets based on core global assets. Lead key campaigns planning, development, execution, measurement, and optimization.
• Partner with digital team and agency to develop digital content and non-personal promotional plans
• Manage agency partners driving the overall planning, maintaining consistency with other functions, and ensuring that they align with overarching corporate goal

The Requirements

• Bachelor’s degree required; advanced degree preferred
• Minimum 8 years of progressive experience with increasing responsibilities in sales, marketing, or related function
• Proven Canadian therapy launch
• Start-up mentality
• Out of the box thinker, solution oriented with ability to see things from start to finish
• Proficiency in developing marketing strategy and tactical plan with an ability to communicate ideas to internal partners and external agencies
• Ability to lead and set direction for customer-facing functions
• Proven ability to learn and adapt strategy/tactics from close partnership with field teams
• Ability to lead without authority and influence cross-functional teams and drive alignment across key stakeholders
• Strong influencing, communication, presentation skills and master collaborator
• Experience managing budgets
• Understanding of relevant regulations and guidelines

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Senior Clinical Trial Associate will support the Global Clinical Operations (GCO) team in study execution and will act as the central contact for project communication and documentation and execution. Reporting to the Head Clinical Operations EMEA you will be responsible for supporting the day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols and under the general supervision of the CTM, Lead or Head of GCO. In this role you will collaborate with GCO members, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

The Role

• Coordinate and attend study team meetings; take, distribute, and file meeting minutes.
• Maintain and generate applicable study trackers and reports (for example: patient enrollment and IRB approvals).
• Overall management of the Trial Master Files (internal and CROs) including managing set-up, maintenance, and periodic QC.
• Coordinate and contribute to the development of study documentation including protocol review, informed consent forms, study plans, essential document packets
• Professionally interact and communicate with internal departments (Legal, Regulatory, Safety, etc.), CROs, and external vendors.
• Maintain knowledge and act as team super-user or subject matter expert for related systems and processes; provide presentations, training, and support to CTA team as needed; provide updates to applicable CTA resources as needed.

The Requirements

• BS/BA/RN degree (or equivalent) in a relevant scientific field preferred.
• Minimum of 5 years of experience working on clinical studies in pharmaceutical, biotech, or CRO setting. Prior CTA experience required.
• Experience with essential documentation for Trial Master Files system (e.g. Veeva Vault).
• Knowledge of drug development, clinical operation processes, medical terminology, and procedures according to FDA GCP/ICH regulatory guidelines.
• Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
• Excellent interpersonal and communication skills with ability to work collaboratively across functional teams.
• Strong organizational and time management skills, and strong attention to detail.
• Knowledge in global regulatory and compliance requirements for clinical research.

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

The Lead, Clinical Operations is responsible for managing clinical studies in ALS and other neurodegenerative diseases.

Reporting to the Head Clinical Operations EMEA, you will manage day-to-day operations of trials with little supervision in a small fast-paced company environment. You are a seasoned clinical operations trial lead, comfortable working independently and experienced managing cross-functional activities internally and externally. As an integral senior member of the Amylyx Global Clinical Operations team you possess strong vendor management skills and experience managing full-service CROs. You are a proactive problem-solver with proficient verbal, and written communication. This is a remote based position; the individual can live in the US, Europe, or Canada.

Responsibilities

• Partner with others in the review, planning, and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and risk management of medical and logistical problems to ensure high quality trial data deliverables on time and on budget
• Communicate trial status, issues, mitigations, and lessons learned to relevant cross-functional stakeholders, including senior leadership.
• Provide oversight of trials and CRO to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other regulations and patient safety standards
• Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, Clinical Study Reports etc.
• Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team
• Collaborate with all cross functional internal and external stakeholders

Requirements

• BS/BA Degree in science or a health-related field is preferred with a strong emphasis on science
• Minimum 8 years of clinical research/operations experience in a pharmaceutical/biotech, CRO setting with at least 5 in pharma/biotech
• Effective project management skills with a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective. On site monitoring experience is a plus
• Experience and understanding of global clinical trial operations; study startup through close-out; strong vendor management skills
• Ability to manage competing priorities, possess strong reasoning skills, and is detail-oriented
• Exceptional knowledge of GCP, ICH and FDA regulations
• Must be able to travel up to 20%, domestically and internationally
• Ability to work independently in a rapidly changing, small company environment and comfortable making risk-based decisions

Preferred Skills:

• Inspection readiness and previous filing experience a plus
• Experience working on global (Including APAC) pivotal clinical studies in a small fast-paced company environment is a plus
• Therapeutic experience in rare diseases or CNS conditions

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.