Longevity Industry Jobs

• Support cross functional teams in processing documents (assist in document editing, review, approvals)
• Assist in process improvements for Document Control Management/Training processes
• Revise SOPs related to Document Control/Training on an as needed basis.
• Help to support the management and maintenance the electronic document management system ensuring Controlled Documents are processed in accordance with Scholar Rock SOPs including creation, revision, approval, and obsoletion of Controlled Documents.
• Help to support the management and maintenance of the training system ensuring new users are trained, accounts are set up appropriately, and the system remains in a state of compliance.
• Maintain internal formatting standards and ensure all documentation are formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates.
• Ensure Document Change Requests are created for document revisions and provide appropriate and applicable information on document revisions; creates Document Change Controls for applicable documents.
• Management of the Document Control/Management and Training Program will require administrative duties such as Scanning, organizing, and maintaining documents; Assisting file migrations; Providing support during audits and inspections

• Minimum of 3-5 years’ experience of Quality Assurance experience in the Pharmaceutical/Biotech Industry.
• Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
• Experience with Veeva Vault required.
• Experience with ComplianceWire, preferred.
• Experience in maintaining cGMP compliance, preferred.
• Excellent organizational skills and the ability to handle multiple priorities and projects.
• Excellent communication skills with the ability to interact with all levels throughout the organization.
• Strong written and verbal communication skills as well as attention to detail

The Director /Senior Director, Regulatory Strategy, reporting to the Head of Regulatory and Quality, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or pipeline programs. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence to the appropriate regulatory agencies.

The Work You'll Be Doing

• Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success
• Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements
• Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
• Serve as point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with regulatory authorities
• Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
• Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
• Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
• Provide regulatory input and support for business development activities
• Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
• Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., PRC, program teams, clinical development teams, study teams)
• Maintain currency of global regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
• Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance
• Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

The Expertise We’re Looking For

• Education in life sciences required; located in the greater Boston area
• 7+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development
• Demonstrated experience of leading successful engagement with key regulatory agencies (e.g., FDA and EMA) from preclinical through global approvals required
• Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
• Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
• Strong written, verbal communication skills, and interpersonal skills
• Capable of managing shifting priorities in a rapidly changing and environment
• Ability to travel domestically and internationally (:10%)

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Reporting to the VP of Medical Affairs, the Director of Medical Communications will be responsible for the oversight of materials and processes for our Medical Communications function. This person will be a hands on leader and will conduct literature reviews, perform reference searches, and develop abstracts, posters, slide decks, review articles and scientific manuscripts. Although a physical presence in Cambridge is preferred, we would consider a remote employee who is able to travel to Cambridge regularly.

The Work You'll Be Doing

• Oversee the execution and track success of communication plans for clinical and commercial stage assets
• Work closely with both internal and external stakeholders to ensure the timely development, review, publication & presentation of documents
• Play a key role in the development and execution of medical affairs strategies
• Manage the internal review, approval and submission processes for Medical Communications team
• Lead the development of slide decks, white papers, training modules, product monographs, HCP/Payor materials, etc. as needed
• Lead the development of company guidelines and SOPs pertaining to Medical Communications
• Collaborate with Medical Publications to ensure consistency with scientific platform

The Expertise We're Looking For

• Advanced life sciences (MS, MA) or other relevant scientific discipline degree. Doctoral degree (PhD, MD or PharmD) preferred.
• A minimum of 5 years of experience in the oversight of scientific documents/publications in the biotechnology, pharmaceutical, medical device, or medical communications industries. Exposure to orphan diseases and/or oncology is a plus.
• Experience with building Med Comm's function to support late stage clinical and product launch activities.
• Expertise in Good Publication Practice, ICMJE guidelines, AMA style and other applicable industry guidelines.
• Strong organizational skills and business planning, including development of a budget and adherence to targets.
• Ability to Interpret and present scientific data in a clear and concise manner.
• Ability to work cross functionally, collaborate, negotiate with and influence stakeholders at all levels of the organization.
• Familiarity with project management tools, electronic literature search tools and obtaining copyright permissions.
• Ability to travel up to 20%.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The Associate Director/Director, Statistical Programming will lead the statistical programming activities for clinical trials, conduct statistical analyses, oversight vendor activities, interact with other functions and support various programming needs. The role will lead the effort to support the coming BLA submission, create GxP compliant analysis outputs, prepare CDISC compliance submission package. Requires deep understanding on data standards (e.g., CDISC SDTM, ADAM, Define.xml ), as well as ICH and regulatory guidelines on data and reporting standards. Contribute to the development and continuous improvement of departmental procedures. This role will report to the Senior Director of Statistical Programming.

Position Responsibilities:

• Lead statistical programming activities for study(ies) and ensure timely deliveries
• Create submission ready data and analysis elements, such as ADaM, TLFs, DEFINE.xml etc.
• Oversight of vendor activities to ensure the quality of vendor deliverable, such as SDTM, ADaM and analysis outputs
• Oversight of vendors to ensure the processes are followed
• Support study team needs as ad-hoc analysis and analysis for publications
• Work cross-functionally across the study team to support other functions programming needs, such as cross-domain data check, safety monitoring outputs, etc.
• Help to improve and innovate internal processes

Candidate Requirements:

• Experienced on leading statistical programming team activities, submission experience is preferred.
• Good project management and communication skills
• Bachelor’s degree is required, Master’s degree in Statistics, Mathematics, Computer Science, Computer Information Systems or Public Health is preferred
• 10+ years of SAS programming experience in pharmaceutical or CRO environments; strong candidate with less years of experience will be considered for appropriate position
• Enjoy coding and innovation
• In-depth knowledge of CDISC SDTM, ADaM, Define.xml , CFR 21 Part 11 compliance, ICH and FDA standards
• Deep understanding of data and system dependencies, validation techniques, and integration of studies for ISS/ISE.
• Thorough knowledge of SAS and working knowledge of different SAS environment (e.g., SAS EG in UNIX and Windows) is required

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The Associate Director, Clinical Drug Supply will be responsible for developing and managing clinical supply for global clinical studies in various phases of development. This position is primarily responsible for ensuring supply chain continuity for Scholar Rock clinical trials and developing and archiving critical documents related to clinical trial management. This position will report to the Vice President, Head of Clinical Operations.

Position Responsibilities

• Collaborates across teams within Clinical Operations to forecast initial and ongoing clinical drug supply needs and demand assumptions
• Collaborates with Technical Operations to ensure Drug Substance and Drug Product availability and provides forecast data for inventory maintenance
• Collaborates with QA to ensure appropriate SOPs are established for all stages of clinical supply chain management
• Collaborate with cross functional teams to develop clinical labeling processes and procedures as well as packaging and shipping requirements for bulk drug substance, drug product and packaged clinical materials
• Create inventory and supply tracking methods and provide updates to the Clinical Teams
• Manage the budget, purchase orders, and invoices for clinical trial supply chain expenses
• Contribute to the development of study and product specific documents, including Pharmacy Manuals, MSDS sheets and other technical documents as required
• Oversee packaging vendors, depots and CMOs on project plans and requirements to deliver material according to program needs
• Support the return and destruction of IMPs from clinical sites and distribution depots
• Manage temperature excursions and/or shipping deviations for each study
• Interface with Clinical/QA to enable initial release of clinical trial material to investigative sites

Candidate Requirements

• Bachelor’s degree with 7+ years experience in Clinical Drug Supply Management in the biotech/pharmaceutical industry
• Ability to work cross functionally with multiple internal teams and external CMOs
• Working knowledge of cGMPs and pharma industry procedures and regulations
• Experience with IRT implementation
• Experience with temperature-controlled shipments and managing temperature excursions
• Experience working with FDA and other global health authorities
• Knowledge of import/export processes and regulations
• Proven success managing clinical trial logistics and clinical supply depots
• Demonstrated excellence in project management—managing, tracking, and measuring project progress
• Requires domestic and international travel – up to 30%

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Want to change the world? Have fun while doing it? Here is your opportunity to join a patient-inspired, creative, collaborative, dedicated, and experienced drug development team that deeply believes in this vision. Our team strives to help patients with serious illnesses by applying innovative thinking and passion towards developing cutting edge monoclonal antibody therapeutics. Around here, we don’t do the “that’s the way it’s been done for a thousand years, so that’s the way we’re going to keep doing it”. Out of the box, in the box…it doesn’t matter. We’re here to do amazing things and want to do what makes sense and is right. Through our science, let’s go and make the world a better place. And, did we already mention have fun while doing it?

The VP or SVP, Head of Regulatory Affairs and Quality, reporting to the CMO, will be a member of the development and medical leadership team and a member of the Portfolio Review Committee. The successful candidate will be responsible for building and leading a high-functioning regulatory affairs and quality team, accountable for regulatory and quality strategy and operations across all clinical and pipeline programs throughout product life cycle. This position requires a seasoned and highly collaborative leader with broad experience to help advance our development pipeline and ensure compliance with global and regional regulations.

The Work You'll Be Doing

• Build and lead a team of high-functioning regulatory affairs and quality assurance team, including regulatory strategy, labeling, CMC regulatory, promotional review, regulatory intelligence, regulatory operations, clinical quality, manufacturing quality, auditing, and quality operations
• Lead the regulatory and quality team to drive the development and execution of global regulatory and quality strategy for both clinical and pipeline programs
• Provide regulatory input and contribute to the development of strategic development strategy and plan as well as portfolio strategy
• Develop regulatory roadmap to inform and guide agency engagement strategy and lead regulatory engagement (e.g., PIND/EOP2 meetings); cultivate and maintain trusted relationships with regulatory authorities
• Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
• Collaborate with technical operations team to develop and implement global CMC regulatory and quality strategy for both clinical and pipeline programs throughout the development and commercial lifecycle
• Ensure strong representation of regulatory and quality voice at key governance bodies and teams (e.g., PRC, program teams, clinical development teams)
• Maintain currency of global regulatory requirements, including CMC guidelines, regulatory and quality trends, and approvals to inform regulatory and quality strategies across portfolio
• Monitor and analyze global and country specific regulatory and quality landscape to assess potential impact on portfolio and implement plans to address issues
• Provide timely review and approval of external facing materials to ensure regulatory compliance
• Provide regulatory and quality support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed
• Provide strategic and technical leadership of quality assurance activities, including cross-functional effort to develop policies, processes, and SOPs on GXP and ensure compliance with global and regional regulations and ICH guidelines
• Identify, resolve or escalate product and quality-related issues that pose risk with respect to the patient, customers or compliance
• Develop systems and processes that support program needs, including but not limited to SOP development and training

The Expertise We're Looking For

• Education in life sciences required; located in the greater Boston area
• 10+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development with 7+ leadership experience building and leading teams
• Demonstrated experience of leading successful engagement with key regulatory agencies (e.g., FDA and EMA) from preclinical through global approvals required
• Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
• Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
• Exceptional communication skills and extensive experience and excellent skills in developing ppt presentations
• Strong written, verbal communication skills, and interpersonal skills
• Capable of managing shifting priorities in a rapidly changing and environment
• Ability to travel domestically and internationally (:10%)

The Special Traits of the Ideal candidate:

• Energized by a vision to change the world through innovation (in both what we do and how we do it); a catalytic leader who strives to make that happen
• Integrity in thought and action, creativity, team-centric mindset, integrative thinking, ability to influence decision-making without dictating, exceptional communication skills, the ability to inspire, and being a “hands-on doer” who leads from the front, not a “politician or presider”

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

• Contribute to developing, troubleshooting, and executing a broad range of quantitative assays, including pharmacokinetic, pharmacodynamic, biomarker, immunogenicity, ligand binding, and cell-based assays to measure mechanism of action and potency.
• Maintain detailed records of experimental protocols and data in laboratory notebooks in accordance with company policy and review others.
• Analyze, interpret, and report experimental results in a small and large group setting.
• Expected to work independently, participate in process improvement initiatives, and may function as a bioanalytical team lead on project team.
• Work and communicate effectively as a team across functional boundaries in a dynamic, fast paced and highly matrixed environment.

• BA/BS or MS in cell or molecular biology, biochemistry or related field with 2+ years of experience in drug discovery research
• Candidates must have experience designing, developing, and performing ELISAs and/or ligand-binding assays
• Experience with the development of pharmacokinetic, pharmacodynamic, and immunogenicity assays for therapeutic antibody drug discovery programs is highly desirable
• Experience working with bioanalytical CROs and regulated bioanalysis is a plus
• Demonstrated ability to work independently in a fast-paced team-oriented environment
• Be able to design, execute, and troubleshoot experiments and propose creative solutions
• Strong written and oral communication skills
• Ability to succeed in a flexible, ambitious, and matrixed research and development environment

• Plan, execute and monitor toxicology studies for advancing candidates through lead optimization, development candidate selection, IND-enabling studies and support advancement in the clinic.
• Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization, and monitor study activities.
• Review, summarize, interpret and report results of toxicology, PK and safety pharmacology studies.
• Ability to both prepare and critically evaluate written scientific and regulatory documents for overall quality, clarity of presentation, and acceptability of scientific interpretation.
• Provide nonclinical study support to research, clinical and regulatory teams (including timing and reporting of all nonclinical studies and assuring compliance with all appropriate regulatory guidance).

• MS/BS in Toxicology, Pharmacology or relevant field; with a minimum of 3-5 years of experience in nonclinical development and proven track record of conducting regulatory toxicology studies at CRO or in a biopharmaceutical setting.
• Experience in coordinating non-GLP and GLP preclinical in vivo studies conducted in both rodent and large animal models, including NHP.
• Experience in designing, conducting, monitoring, and interpreting discovery and exploratory toxicology, PK, studies to assist lead optimization and candidate selection efforts (experience with biologic drugs preferred).
• Experience in management of external CROs. Familiarity with GLP requirements and ICH guidelines.
• Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology and pathology assessing the clinical relevance and impact.
• Strong interpersonal skills to work effectively in a team setting. /.
• Critical problem solving and organizational skills required.
• Excellent oral and written communication capabilities, essential for successful contributions.

• Processing invoices in NetSuite
• Receiving and responding to emails in the AP inbox (for instance, payment status inquiries, new vendor setups)
• Prepare weekly check-runs and initiate payments
• Separating invoices between Prendio/NetSuite/P-Cards (credit card receipts)/Packing Slips
• Ensuring proper coding in the systems, including amortization schedules and capex items
• Working with business owners to determine in-service dates for capex items and purchase order changes
• Preparing month end closing entries and reconciling GL accounts around prepaid expenses and accruals
• 1099 filings
• Involvement in SOX controls to adhere to public company regulations
• Additional projects as needed

• Bachelor's degree in accounting or related field
• Proficient in Word, Outlook, Excel, PDF
• Experience working in NetSuite is a big plus
• Experience with filing 1099 forms

• Perform all aspects of histology including tissue processing, embedding, sectioning, and staining for multiple projects.
• Management of external laboratories (e.g., CROs), which includes vendor selection, technical oversight, budgets, and maintaining project timelines.
• Develop and optimize immunohistochemistry (IHC) assays with automated platforms.
• Develop in-situ hybridization (ISH) and multiplex immunofluorescence (mIF) protocols.
• Independently prepare and maintain all necessary pathology lab instruments and reagents.
• Independently lead and contribute to experimental design, planning, and execution of research projects.
• Support, organize, and maintain a digital image repository for all staining results.
• Identify and design flexible solutions to complex digital analysis algorithms.
• Critically analyze and interpret pathology results from pre-clinical animal models.

• BS/MS in biology or related discipline with 10+ years industry lab experience or a PhD with 5+ years of related lab experience, preferably in industry.
• Experience with routine histology workflow (processing, embedding, sectioning, etc.).
• Familiarity with Leica or Ventana automated instruments.
• Knowledge of light microscopy, optics, and standard calibrations.
• Demonstrated familiarity with designing and troubleshooting image analysis solutions with commercially available software (e.g., Visiopharm, HALO, QuPath).
• Clinical assay development experience is favorable.
• Proficiency with Microsoft Office, GraphPad Prism, and statistical software. Working knowledge of R, Spotfire, or VBA is a plus.
• Strong communication skills (oral and written).

• Implementing, optimizing and supporting the company’s cloud infrastructure and applications
• Manage administration aspects of O365 and other communication and collaboration platforms
• Assist with administration of other apps including but not limited to NetSuite, DocuSign, Okta, FreshService
• Setup and support cloud app integrations and automated provisioning
• Potential to get involved with Cloud App security and Cyber Security initiatives using tools like Arctic Wolf, AvePoint, and SentinalOne
• Experience with gathering business requirements, mapping business processes and designing workflows within applications
• Work collaboratively with IT teams, internal business partners and external vendors to identify, understand, implement, and support new business capabilities, optimize processes and drive operational efficiency
• Plan and execute projects that align with the company’s strategic goals and projected growth.
• Manage and contribute to major aspects of compliance such as Sarbanes-Oxley (SOX), 21 CFR Part 11 Compliance and Data Privacy (GDPR, CCPA, HIPAA)
• Foster a positive employee relations environment and a culture of continuous improvement, partnership, and teamwork using good and consistent management principles
• Foster effective team interaction, collaboration and accountability

• Knowledge about cloud concepts such as SaaS, IaaS and PaaS, as well as integration of cloud systems
• Experience with Global Administration of 0365
• Experience with Amazon Web Services
• Experience in one or more areas: Cloud App Engineer, Infrastructure System Engineer, Information Security Engineer
• In depth knowledge regarding cybersecurity and data privacy concepts
• Collaborative, open-minded, and have experience with the selection, implementation, rollout and support various systems and Cloud Applications which support different processes.
• Strong interpersonal skills with a “seek to understand” mentality
• Experience with SOX and/or 21 CFR Part 11 Compliance
• Life sciences industry experience would be great but a person who can work autonomously on projects and be willing and able to adapt to new responsibilities is much more important.

• Provide strategic and medical/scientific leadership to the apitegromab therapeutic program by leading the Medical Affairs subteam to develop and execution of the Global Medical Affairs strategy in alignment with the apitegromab program strategy
• Accountable for strategic oversight of all Global Medical Affairs activities
• Represent Medical Affairs at Program Team and other cross functional meetings as needed (eg, Global Brand team)
• Collaborate with Clinical Development, Regulatory, Commercial, Clinical Development Operations and other functions as needed to establish portfolio strategy, ensuring appropriate alignment, prioritization, and execution of apitegromab strategy and plans
• Partner with cross-functional stakeholders to define and prioritize evidence gaps, develop and implement evidence generation strategy (e.g. natural history studies, phase 4 studies, disease registries, post-hoc analyses etc) to address strategic gaps and inform evidence-based clinical and payer decision making
• Provide medical oversight of prospective and retrospective observational studies, comparative effectiveness research, chart reviews, registry studies, and other evidence generation projects
• Partner with Medical Communications to ensure timely dissemination of scientific data (publications and congress presentations)
• Work closely with Global Marketing to define key stakeholder engagement strategy and oversee engagement activities of global KOLs
• Partner with Medical Communications and Field Medical to develop and deliver high quality scientific and skill-based training to Medical Affairs team, globally
• Other duties and responsibilities as required

• Must have PharmD, PhD, MD or equivalent
• 7+ years of demonstrated high-level professional knowledge and skills in the areas of Medical Affairs and R&D in the pharmaceutical or biotech industry
• 3+ years in leading teams in R&D (Medical Affairs, Medical Operations, and/or Clinical Development)
• Demonstrate experience in working with rare or genetic diseases in a fast clinical and product development timeline
• Knowledge of the biopharmaceutical industry and evidence generation with an understanding of key regulatory bodies
• High degree of professionalism, maturity, and confidentiality
• Strong written and verbal communication skills as well as strong leadership and interpersonal skills
• Demonstrated reputation as a well-respected, dynamic team leader, player and coach
• Capable of managing shifting priorities in a rapidly changing and environment
• Ability to deliver on company global program goals and objectives as they pertain to Medical Affairs
• Ability to affect positive organizational change at the company and team levels
• Travel will be required (approximately 25%

• Provide medical and strategic leadership for the clinical development plan related to one or more studies of the apitegromab program, in close partnership with the program team.
• Develop medical content and provide medical expertise for study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions.
• Serve as the medical monitor for one or more clinical studies, including reviewing and approval of medical monitoring plan, safety plan, and protocol deviation plan, as well as day-to-day study related medical decisions.
• Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analyses.
• Contribute medical content and expertise in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate, and interface with regulatory authorities as appropriate.
• Provide medical leadership for cross-functional teams, including external innovation/business development.
• Represent SRRK to outside medical personnel in the development of clinical protocols and study conduct; represent SRRK to outside stakeholders.
• Provide content leadership in the analysis and interpretation of clinical trial data and drive timely communication of data both internally and externally.
• Provide medical leadership in cross-functional effort in the evaluation of new indications for muscle-related therapeutics.
• Work within compliance to all applicable GCP/ ICH regulations

• MD, MD/PhD, or equivalent
• Drug development experience required; clinical development experience in neurology and/or neuromuscular therapeutic area highly desired but not required
• 3+ years of experience in the biopharmaceutical clinical and/or medical function, with 2+ years of clinical development experience
• Expertise in innovative clinical study design, analysis of clinical data and publications and working knowledge of biostatistics and pharmacology
• Understands the drug development process from pre-IND through BLA
• 3+ years of experience in clinical R&D as investigator and/ or within the pharmaceutical/ biotech industry
• Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Ability to work independently to resolve challenges with strong interpersonal and communication skills.
• In-depth knowledge of ICH-GCP and other application regulatory guidelines
• Highly organized, outcome-oriented, self-motivated performer
• Excellent interpersonal skills and conflict management and negotiation skills
• Ability to travel domestically and internationally (:20%)

• Energized by a vision to change the world through innovation (in both what we do and how we do it); a catalytic leader who strives to make that happen
• Integrity in thought and action, creativity, team-centric mindset, integrative thinking, ability to influence decision-making without dictating, exceptional communication skills, the ability to inspire, and being a “hands-on doer” who leads from the front, not a “politician or presider”

• Serves as a representative of Scholar Rock to CRO, study vendors, and site staff
• Review Monitoring Visit Reports from the CRO
• Monitor studies or perform co-monitoring visits as required per the Sponsor Oversight Plan or as needed
• Attend Qualification and Site Initiation visits
• Track Metrics related to Sponsor Oversight and the Monitoring Plan
• Lead the Trial Master File processes
• Assist the Clinical Trial Manager in the review of ICFs and essential documents
• Track clinical supply shipments and manage shipment logistics
• Participate in Investigator Meeting planning
• Collaborate with the CRO counterpart
• Performs clinical oversight of study site management/monitoring activities in compliance with ICH-GCP, SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
• Minimum 80% overnight travel, including international travel, required

• BS/BA degree in a scientific discipline
• Languages: Fluent in both written and spoken English
• Minimum of 2-3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical and/ or CRO company
• Highly organized, outcome oriented, self-motivated performance
• Thrives in a fast-paced and evolving environment
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.)
• Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Strong written and oral communication skills
• Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable

• Apply advanced scientific principles, theories, concepts, practices and standards to analytical development and product characterization
• Responsible for sample preparation and analysis, maintenance and operations of analytical instruments such as LC-MS, HPLC, Maurice (cIEF, CE-SDS), and MFI among others
• Responsible for performing routine analytical testing, formulation development and stability testing, fraction collections, force degradation studies, extended characterization of antibodies
• Write data summary and technical reports
• Participate in authoring, and reviewing IND, IMPD, BLA, and MAA sections
• Author method development and qualification reports and test methods
• Actively participate in building an internal analytical team with the objective of being a center of excellence of monoclonal antibody characterization, including identification of posttranslational modifications, and establishing degradation pathways to support developability screening and formulation of early phase molecules and comparability of late stage molecules for drug candidate nomination, IND submission and BLA filing.

• Ph. D. in a relevant discipline (chemistry, biochemistry, or related field) or MS with a minimum 3 years of relevant industry experience or BS with a minimum of 5 years of relevant industry experience.
• Hands-on experience and extensive knowledge in HPLC, LC-MS and other related analytical techniques for analyzing proteins and peptides
• Knowledge of protein modifications and degradation
• Demonstrated technical writing skill
• Understanding GLP, and GMP working environment
• Good balance between scientific thinking and compliance
• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
• Working with the sense of urgency

• Manage one or more CDMOs as the primary point of contact in support of GMP production of Scholar Rock products, including activities from initial cell banking to fill/finish.
• Ensure that all contractual obligations with our CDMOs are met to Scholar Rock Quality standards, including on-time manufacturing, QC release testing and batch disposition
• Establish business processes and cross-functional relationships with internal and external partners, including senior leaders at the CDMO
• Communicate status of projects and activities at CDMOs to Scholar Rock management and stakeholders
• Work with legal and finance groups on contracts for new and existing vendors (i.e., supply agreements, confidentiality agreements, purchase orders, etc.)
• Manages budget, contracts, and invoices for CDMO manufacturing activities.
• Manages internal and external inventory of product retains and samples
• Collaborates with Supply Chain to ensure on-time Drug Substance and Drug Product availability and provides forecast data for inventory maintenance
• Develop, review and approve technical manufacturing documents such as production records, distribution instructions, and specifications.
• Contribute to the development of study and product specific documents, including MSDS sheets and other technical documents as required
• Other duties may be assigned

• Bachelor’s degree in a technical or scientific discipline
• Minimum 8 years of relevant experience in biologics contract manufacturing management
• Working knowledge of cGMPs and pharma industry procedures and regulations
• Experience working with CMO DS and DP operations
• Experience working with FDA and other global health authorities
• Demonstrated excellence in project management—managing, tracking, and measuring project progress
• Requires domestic and international travel – up to 25%

• Management, oversight, and operation of medical writing team responsible for development of clinical and regulatory documents
• Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs)
• Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
• Independently author and manage others in creation of clear and concise submission-ready documents
• Act as subject matter expert for development of data transparency deliverables
• Develop and maintain SOPs, style guides, and quality control checklists that drive consistency across documents and processes
• Build and mentor medical writing team
• Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections
• Plan strategically, anticipate problems, and recommend process improvements to address current and future needs

• Advanced degree in life sciences preferred; minimum BS/BA required
• 10+ years’ experience in a medical writing capacity within drug development
• Prior direct experience leading medical writing teams responsible for global marketing authorization applications
• Extensive knowledge of English grammar and American Medical Association style guide
• Demonstrated experience mentoring medical writers, managing project work of internal medical writers, and supervising external (contract/vendor) writers
• Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
• Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
• Proactive team player, collaborative, and flexible

• Develop and implement clinical project plans in accordance with corporate objectives
• Evaluate outsourcing partnerships and define go-forward strategy for identifying, engaging and managing long term strategic partnerships
• Provide oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical trials.
• Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
• Proactively develop and implement hiring plans to attract, recruit, on-board and retain best in class talent to effectively execute against program milestones
• Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trial
• Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
• Identify, evaluate, and recruit clinical trial sites
• Contribute to global clinical / regulatory submissions
• As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency
• Undertake line management responsibilities for assigned team members, serving as coach and mentor
• Contribute to the development of departmental SOPs and work instructions
• May require travel, including international travel

• Bachelor’s in a scientific discipline; advanced degree preferred
• Minimum 10 years of experience in a biotech/pharmaceutical/ CRO setting, principally in oncology drug development; minimum 7 years of clinical operations experience; minimum 5 years in a supervisory role
• Proven record of success running oncology/ immuno-oncology drug development trials
• Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
• Highly organized, outcome oriented, self-motivated performance
• Comfortable in a fast-paced environment with the ability to adapt to change
• In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
• Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
• Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents

• Develop, implement, and execute translational research strategies to support clinical and pre-clinical programs in multiple disease areas.
• Apply expertise in drug discovery to lead overall translational research strategy for clinical and pre-clinical programs.
• Drive/oversee collaboration with program team, internal research group, external vendors, and consultants for preclinical and clinical assay development, execution, and data analysis.
• Be a key contributor to overall clinical program strategy and indication expansion research activities, and to collaborate with research team to oversee additional supportive preclinical work.
• Plan and execute pre-clinical studies to test biological hypotheses, executing on clinical biomarker evaluation, and managing CROs to achieve departmental objectives
• Lead and oversee relevant sections of clinical and regulatory documents for biomarkers.
• Communicate scientific progress to management and stakeholders, present work at both internal and external meetings as well as BD discussions.

• Ph.D. with 8+ years of research experience in pharmaceutical drug discovery and a proven track record in advancing drug candidates through pre-clinical development.
• Experience in developing and implementing biomarker strategies for rare diseases, particularly neuromuscular disorders, is required. Experience in immunology is a plus.
• Experience and/or working knowledge of a range of in vitro and ex vivo assay methods that can be applied to cells or biological samples obtained in preclinical or clinical settings such as multiplex IHC, LC-MS, immunoassays (e.g., ELISA and MSD). Experience with multiparameter flow cytometry, transcriptomic techniques (RNA-seq), digital pathology, or human primary immune cell assays is a plus.
• Experience working with teams in support of preparing documents and reports for internal governance committees and regulatory agencies, including INDs.
• Strong interpersonal, influencing, problem solving and negotiating skills, together with evidence of having used these to support collaboration(s); both within an organization and with external partners.
• Ability to prioritize and manage multiple tasks simultaneously while keeping to timelines and milestone projections.

• Lead a team of Medical Directors and Clinical Scientists, ensuring strong representation of clinical development at the program team and development leadership team
• Provide medical vision and leadership in the creation and execution of development strategies in order to establish a clear path initially to clinical proof-of-concept and ultimately to regulatory approval
• Provide medical and scientific leadership, including hands-on authoring, for the development of clinical development plans, study protocols, Investigator Brochures, submission/ registration documents, publications, etc.
• Provide medical leadership and input in cross-functional project team activities, including business development activities, discovery, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety.
• Responsible for providing or supervising medical monitoring activities in support of AE reporting and patient safety for all clinical trials across a development program
• Liaise with investigators, US and Ex-US health authorities, IEC/IRB, consultants, KOLs, SABs, academic institutions and CROs, elucidating the scientific rationale and vision for the clinical programs
• Expertly analyze and interpret data, and clearly communicate results both internally and externally to a variety of audiences
• Lead efforts to identify, build relationships and communicate with key investigators and trial sites
• Medically lead the evaluation of new indications for muscle-related therapeutics, and formulate and execute development strategies to pursue them
• Work within compliance to all applicable GCP/ ICH regulations

• MD, MD/PhD, or equivalent
• Drug development experience required; clinical development experience in neurology and/or neuromuscular therapeutic area highly desired but not required
• 10+ years of experience in the biopharmaceutical clinical and/or medical function, with 5+ years of clinical development experience
• Expertise in innovative clinical study design, analysis of clinical data and publications and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics
• Understands the drug development process from pre-IND through BLA
• 5+ years of experience in clinical R&D as investigator and/ or within the pharmaceutical/ biotech industry
• Experience interacting with health authorities in the US and EU
• In-depth knowledge of ICH-GCP and other application regulatory guidelines
• Highly organized, outcome-oriented, self-motivated performer
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Ability to forge and nurture key partnerships and collaborations with the external scientific community
• Ability to travel domestically and internationally (:20%)

• Energized by a vision to change the world through innovation (in both what we do and how we do it); a catalytic leader who strives to make that happen
• Integrity in thought and action, creativity, team-centric mindset, integrative thinking, ability to influence decision-making without dictating, exceptional communication skills, the ability to inspire, and being a “hands-on doer” who leads from the front, not a “politician or presider”

• Independently execute and analyze in vivo pharmacology assays including downstream analysis to advance therapeutic candidates.
• Lab based support of bioanalytical and translational biomarker efforts across in vivo pharmacology models.
• Independently develop, execute, and analyze mechanistic studies including in vitro assay development with primary human cells.
• Support our culture of scientific excellence and cross-functional collaboration.
• Maintain detailed records of experimental protocols and data in laboratory notebooks in accordance with company policy.
• Ensure each activity is effectively prioritized with appropriate use of internal resources, CROs, and academic / industrial collaborations to deliver optimal results.
• Analyze, interpret and present experimental results at internal and external meetings.
• This position will include a significant laboratory bench component.

• PhD in pharmacology, molecular biology, or related field with 0-1 years of related experience, MS with 6+ years of experience, or BS with 8+ years of industry experience in similar roles will be considered.
• The preferred candidate will possess a strong understanding of molecular and cell biology methods and pharmacology. Experience designing and conducting in vivo experiments in preclinical models of human disease and managing external CROs is a strong plus.
• Skilled in standard molecular biology techniques such Western blot analyses, ELISAs, and quantitative PCR. Experience with mammalian cell culture, including primary cells and cell-based assays, is a plus.
• Familiarity with antibody therapeutics and pharmacology models of fibrosis are a plus.
• Demonstrated intellectual curiosity, flexibility, and a willingness to contribute to laboratory experiments
• Self-motivated with strong collaboration skills and comfortable operating independently and within teams.
• Ability to balance resources and priorities to concurrently deliver on multiple objectives under ambitious timelines and thrive in a small, interactive, fast-paced, and entrepreneurial drug-discovery environment.
• Excellent written and oral communication skills

• Manage calendars of Executives and other designated team members; review and coordinate requests for meetings
• Coordinate domestic and international travel arrangements, including respective expense reports
• Maintain relationships with internal and external stakeholders (employees, Board members, etc)
• Organize meeting notes and minutes and maintain various meeting schedules
• Coordinates agendas, manages scheduling and meeting minutes for various internal and external meetings
• Be present in the office to handle the logistical aspects of meetings and events
• Assist in the preparation and management of company materials; drafting, editing and proofing various types of documents, including agreements, memos, correspondence and presentation materials (e.g., PowerPoint presentations)

• Must have proven track record of supporting c-suite and senior-level executives. Experience in a Biotech or Pharma setting a significant plus
• Demonstrated ability to establish priorities and act quickly and professionally.
• Must be flexible with ability to multi-task assignments and excellent organizational and problem-solving skills
• Possesses a strong attention to detail and the ability to follow through in completing assignments/projects
• Thorough knowledge in the use Microsoft Office suite (Word, PowerPoint, Excel, SharePoint, SmartSheet) is required
• Outstanding customer service skills
• Demonstrated ability to handle sensitive information, which has tactical and strategic importance
• Ability to work independently with discretion and confidentiality