Longevity Industry Jobs

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.   

Reporting to the Senior Vice President of Clinical Development, the Senior Medical Director, Clinical Development will play a critical role in developing and executing the ongoing clinical trial strategies for our Oncology products. 

Major Duties/Responsibilities:

• Develop clinical trial strategies for Oncology products in clinical development.
• Design, plan, analyze, report, and publish ALX Oncology sponsored clinical trials.
• Work with cross functional teams to support execution of each assigned study.
• Develop collaborative relationships with Research, CMC, and Business Development, stakeholders.
• Work with multidisciplinary team to support data cleaning and database lock activities.
• Work with multidisciplinary teams to ensure quality oversight of the study (quality, regulatory, and safety).
• Lead the development of clinical sections for regulatory submissions.
• Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trial(s).
• Develop working relationships with key investigators in the oncology area to maximize scientific quality in clinical study design, execution, reporting, and publication.
• Contribute to the development of clinical sections of regulatory documents (i.e., Investigators’ Brochures, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
• Oversee trial-related advisory boards, investigator meetings.
• Work with CRO data management and clinical sub-team on data integrity and analysis for study and planned/actual filing activities as required.
• Serve as the external clinical “face” of the program in interactions with investigators, development partners, and advisory boards as needed.
• Collaborate with research and preclinical development scientists to support regulatory submissions (i.e., Breakthrough/FastTrack Designation, pre-IND an IND submission for new drug candidates).
• Hire and supervise employees, both directly and indirectly.
• Oversee performance management and career development for direct reports.

Qualifications:

• MD or MD PhD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty required.
• Minimum 10 years clinical research experience in Oncology Clinical Development within a biotechnology and/or pharmaceutical company.
• Demonstrated leadership overseeing development programs with multiple assets across solid and hematologic indications.
• Expertise in the design, execution, and reporting of late-stage clinical trials in Oncology with small and/or large molecule drug candidates.
• Broad understanding of Oncology, Internal Medicine, and Clinical Pharmacology.
• Excellent working knowledge of FDA and EMA regulations and expectations, GCPs, ICH guidelines, and clinical drug development.
• Strong communication and collaboration skills.
• Comfortable with Windows, Outlook, PowerPoint, Word, Excel, and with accessing and working with IVRS and electronic data capture systems.

Salary: $240,000-$300,00 DOE  

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.   

Reporting to the Head of Biometrics, the Associate Director/Director statistical programming will support oncology drug development, providing programming expertise and oversight to the clinical development. 

Key Responsibilities:

• Lead SAS programming activities, to the agreed timeline, budget, and quality in accordance with Company study contacts and SOPs
• Works with biostatisticians, develops data specs, analysis datasets and analysis outputs per requests for internal medical monitoring, CSR and submission need
• Works with data managers, generates ongoing outputs to support data cleaning and enhance data integrity
• Provides programming expertise to review/QC the programming work provided by CRO, including timeline along with QC outputs, datasets, and programming related documents, and debugging programming errors
• Through oversight and effective delegation, ensure SAS Programming activities on assigned studies are completed accordingly within the scope of the study contract and manage progress against the study contract and project plan, driving all Programming activities to their conclusion while maintaining accurate resource forecasts. Lead study team members, providing study specific training and guidance where appropriate
• Develop SOP for Statistical Programming with collaboration with cross-functional teams
• Develops, manages, and maintains analysis data and reporting deliverables. Ensures timely, targeted, and accurate reporting and outcomes
• Ability to work within a team and work independently

Education and Experience:

• Bachelor’s Degree in statistics, computer science or another related science field with a minimum of 6 years (10 years for Associate Director) of SAS programming experience with clinical trial data OR Master’s Degree in statistics, computer science or another related science field with a minimum of 4 years (8 years for Associate Director) of SAS programming experience with clinical trial data
• Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines
• General knowledge of regulatory requirements and drug development process
• Excellent organizational skills and good verbal and written communication skills
• Ability to work independently as well as lead programming teams
• Strong communication skill set with peers, business partners, and Sponsors
• Leadership skills to lead project team to deliver high quality deliverables on time and work directly with the Sponsor to meet the project delivery expectations

Salary Range: 

Senior Manager or Associate Director $145,000-$190,000 DOE 

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology Inc. is a publicly-traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next-generation CD47-blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX is headquartered in South San Francisco, California. For more information about us, please visit www.alxoncology.com.   

We are seeking a highly talented individual for the Associate Clinical Trial Manager position. This role will be responsible for providing operational support for studies conducted by the ALX Oncology team, and work in partnership with internal colleagues, external partners, and clients to ensure delivery to time, quality, and cost expectations. 

Responsibilities:

• Provide high quality assistance supporting ALX Oncology’s clinical trials according to regulatory requirements and company SOPs within budget and timelines
• Communicate effectively with colleagues and vendors
• Perform various job functions including but not limited to the following: tracking study specific documents, i.e. regulatory documents, enrollment and site activation, sample tracking, TMF maintenance, etc.
• QC review of the trial master file
• Contribute to the development of study specific tools
• Coordinate and arrange meetings, and record meeting minutes  

Qualifications:

• BS/BA in a relevant scientific discipline is preferred
• Minimum 2 years related experience, preferably in the pharmaceutical industry or equivalent
• Knowledge of applicable regulatory guidelines (i.e. ICH and GCP)
• Possess a general understanding of clinical trial issues, strong attention to detail, and meticulous follow-through
• Proficiency using Microsoft Outlook, Word, PowerPoint, and Excel
• Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures in a fast-paced environment
• Exceptional oral, written, and interpersonal skills
• This is a hybrid role with the expectation that the candidate will work on-site a minimum of 2-3 days per week.

Salary:

$100,000-$120,000 DOE

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

The Clinical Scientist will be a critical member of a multi-disciplinary team supporting the overall clinical development of evorpacept. In this role, the candidate will participate in the creation of clinical development and regulatory strategy; analyze, summarize and present clinical study data; draft relevant sections of study protocols and key regulatory documents; effectively engage internal and external study teams. This is an exceptional and unique opportunity to gain experience in clinical development in close collaboration with the clinical lead at a successful and fast-paced clinical-stage biopharmaceutical company.

Responsibilities include, but are not limited to:

Clinical Trial Oversight: review and provide content for ICFs, protocol amendments, and regulatory documents; assist with data cleaning to support outputs for regulatory documents, external data presentations, and database lock activities; author and review CRFs; provide CRO oversight, in conjunction with clinical operations, for assigned clinical studies; support site protocol training; ensure trial conduct in accordance with GCP and applicable regulatory requirements.

Clinical Strategy: provide input on major clinical trial milestones and timelines; assist with authoring of clinical sections for regulatory documents (e.g., Investigators’ Brochures, IND/BLA submissions, responses to Health Authority queries); provide strategic direction for data listings, SAP, and DM plan; assist with clinical indication and protocol planning; participate in Health Authority meetings as requested; partner with clinical lead to maintain study alignment with company objectives; participate in drafting of scientific publications.

Data Analysis: collaborate with study clinician, pharmacology, biostatistics, translational, and operations to ensure appropriate and accurate study data collection; analyze, review and summarize clinical safety and efficacy data from ongoing clinical studies; collaborate with research, preclinical development and translational scientists to support and analyze pharmacodynamic study data.

External Collaboration: partner with clinical lead to develop working relationships with study investigators and key opinion leaders; conduct external calls, meetings, and study related advisory boards to advise on clinical development strategy and protocol design.

Requirements

• Minimum of Doctorate degree, PharmD, or equivalent with postgraduate training in oncology or related specialty with 5 years of relevant experience in clinical trial conduct, clinical data collection, analysis, and interpretation.
• Proven track record of scientific publications.
• Experience with FDA regulations and expectations, GCP, ICH guidelines, and clinical drug development. 
• Strong verbal and written communication skills and collaborative attitude.
• Highly motivated and able to work both independently and collaboratively in a fast-paced environment with a desire to learn and tackle new challenges.
• Domestic and/or international travel may be required.
• Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home). 

Salary: 

Clinical Scientist: $160,000-$190,000 DOE

Senior Clinical Scientist: $200,000-$240,000 DOE

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

Under the general direction of the Head of Pharmacovigilance/Drug Safety, the Safety Operations Director is primarily responsible for strategic planning, oversight, and management of pharmacovigilance operational activities.

Key Responsibilities

• Provide oversight on all outsourced case processing activities, including but not limited to establishing and monitoring key quality and compliance metrics and ensuring compliance with safety data exchange activities. 
• Assist with the development and maintenance of drug safety related SOPs, policies and work instructions.  
• Review safety management plans, case report forms, guidelines, and other safety documents, as needed.
• Participates in the drafting and implementation of pharmacovigilance contracts and agreements.
• Provide support for safety sections of clinical documents, including the review of the safety portion of protocols and other documents, as needed.
• Collaborate cross functionally with other departments including clinical, biostatistics, data management, clinical operations and regulatory affairs with respect to safety related issues.
• Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities.
• Participate in addressing drug safety-related questions from Regulators or to support company internally.
• Prepares training materials for internal and external safety presentations, as applicable.
• Performs other duties as assigned.

Education, Skills and Experience

• Health science related degree: Nursing (RN, BSN, MSN or NP), PharmD, PhD or MD.
• Minimum of 8 years of experience in the pharmaceutical industry or CRO, with 5 years in drug safety or relevant experience.
• Experience and working knowledge on FDA safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GVP) and other applicable safety and regulatory guidance documents.
• Skilled at people management including overseeing and managing outsourced vendor activities in a compliance/regulated field.
• Strong experience with drug safety databases such as Argus, and electronic data capture (EDC) systems, MedDRA and WHO Drug dictionary coding.
• Strong verbal and written communications and presentation skills.
• Proven problem solving, decision-making, and interpersonal skills.

Salary

Director: $200,000-$250,000 DOE

Senior Director: $250,000-$290,000 DOE 

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

Under the general direction of the Head of Pharmacovigilance/Drug Safety, the Director of Clinical Safety Science is responsible for overall clinical risk management and safety surveillance of assigned investigational and marketed drugs. The individual in this role will provide program-specific scientific direction and guidance regarding the implementation of an asset safety profile for a matrix team who are typically assigned to support the program. They will lead their team members and work with contract employees to define long-term safety- related objectives for all ALX programs, acting as the main point of contact for safety for wider cross-functional leads; being responsible for the high-level safety program design/plan; guiding the scientific approach to the acquisition, monitoring, analysis/evaluation and communication/reporting of program-specific safety information. The individual will articulate the overall design and the requirements of the defined safety strategy, in the context of development programs and medical value narratives. This individual is accountable for ensuring that program-specific safety communications and patient risk management approaches are implemented and can be demonstrated to be effective in achieving their defined aims. This position reports to the Head of Pharmacovigilance/Drug Safety and will oversee teams in safety- related and benefit-risk decision-making activities across ALX programs. The individual will effectively engage cross-functional leads as the safety point of contact.

Key Responsibilities

• Leads proactive pharmacovigilance signal detection and risk management planning for designated ALX Oncology products, including signal identification, evaluation, interpretation of safety signals and trends and communication (written and verbal) of safety risks.
• Collaborates with interdepartmental stakeholders from Clinical Development, Regulatory Affairs, Biostatistics and Data Management, as well as with Contract Research Organizations (CROs), business partners to manage and evaluate safety signals across ALX products.
• Support product development activities via internal and contracted Risk Management/Safety Teams and Product Development Teams and other related sub- team participation, including participation in project teams relevant to the development of new compounds and the further study of future marketed compounds.
• Work closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation.
• Lead and/or participates in the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, informed consent/assent forms, clinical study reports/synopses, Integrated Summary of Safety)/Common Technical Document (CTD) submissions and other documents as needed; ensure risk-reduction strategies are implemented timely and appropriately in relevant documents.
• Lead and/or participate in preparation of aggregate safety reports (e.g.; DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans (RMPs) under the guidance of the Head of Pharmacovigilance/Drug Safety.
• Responsible for all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use and ensuring completeness of safety information in worldwide package reports.
• Support risk management activities such as contributing to recommendations for pharmacovigilance actions and making recommendations for labeling.
• Ensure the safety sections of Company product reports are medically and scientifically appropriate.
• Analyze and summarize the findings from available safety data to support decisions.
• Supervise the activities of others in the execution of safety data analysis and medical writing as needed.
• Responsible for the development of future worldwide post-market risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.

  Education, Skills and Experience

• MD degree or equivalent (e.g., DO, MB), PharmD, or PhD with knowledge in malignant hematology and oncology
• An equivalent combination of education and experience may be considered.
• Preferably have experience in clinical medical practice and will typically possess at least 5 years of experience in clinical drug safety-related role.
• Principled and strong written and verbal communications and analytical skills.
• Drug safety, pharmacovigilance and/or risk management industry experience in both the investigational and post-approval environments
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies.
• Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI.
• Proficiency in Microsoft Office; Argus Safety Database experience is a plus.
• Efficient in time management and multi-tasking.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).

Salary: $200,000-$250,000 DOE 

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

Reporting to the Head of Biometrics, we are seeking an exceptionally talented individual to provide data management expertise for the Company’s lead program, evorpacept. The Associate Director, Clinical Data Management will work in an outsourced data management model, and manage and perform the end-to-end clinical data management activities for their assigned clinical program, while ensuring the highest level of data quality and compliance. This position will be an individual contributor role that will lead data management activities. This individual will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner, and will provide input into Biometrics strategy and implement department initiatives. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures.

Key Responsibilities and Success Factors:

• Serve as a data management expert and be the CDM lead for assigned clinical studies on multidisciplinary project teams
• Deliver high quality data for analysis and study milestones
• Review protocols from a CDM perspective and provide functional-expert feedback
• Review and approve key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements
• Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor
• Oversee data cleaning activities executed by the CRO and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
• Collaborate with internal Biostatistics, Medical Monitors and Clinical Operations on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into CRO DM activities.
• Develop SOP for Data Management with collaboration with cross-functional team
• Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO and ALX project team
• Monitor vendor performance to ensure timelines and data quality standards are met.
• Ensure compliance of clinical data management processes with applicable regulations and guidelines
• Help identify and support solutions to manage complex issues and escalate to senior management as appropriate
• Perform work and process redesign to improve individual and team effectiveness
• Ensure deadlines are met and inform key stakeholders of project/program status
• Promote constructive, effective relations with and between team members. 
• Ability to work within a team as well as independently
• Provide leadership and direction for department strategic initiatives 
• Work with Head of Biometrics, Senior Management and Human Resources to identify and justify resource needs, develop staffing plans, recruiting process within Biometrics 

Education and Experience:

• BA/BS or higher preferably in math, science or health-related field with a minimum of 10 years of experience in clinical data management across phase 1- 3 clinical trials. At least 6 years of the overall experience require acting as a study lead data manager
• Experience in regulatory GCP inspections/audits is a plus
• Comprehensive experience working with clinical database systems
• Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR
• Successfully manage clinical data management vendors, contractors and service providers for program deliverables 
• Managerial and oversight experience with junior level data managers preferred
• Experience in Oncology and/or Immuno-oncology trials preferred
• Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
• Excellent verbal and written communication skills and interpersonal skills
• Strong analytical and problem-solving skills
• Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home). 

Salary: $160,000-$190,000 DOE

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

Reporting to the Head of Biometrics, the Director of Biostatistics will support oncology drug development, providing statistical leadership and oversight to the development plans, regulatory interactions, and commercial evaluation of investigational compounds in one or more indications. We are seeking an outstanding individual to guide the analytical aspects of our clinical development programs, inform study design, develop and implement novel statistical and computational tools for analyzing trial data, and lead the reporting and analysis of deliverables. The qualified candidate will have a proven track record of functional leadership and mastery of statistics in drug development.

Key Responsibilities and Success Factors:

• Statistical leadership to early and late-stage oncology clinical trials: developing trial design options and providing high quality decision support
• Provide strategies for clinical study design, endpoint selection, sample size calculation, randomization schedules, statistical analysis plans, and data interpretation in collaboration with all team members including programmers, data manager, medical writers and clinical development
• Evaluate and implement innovative designs and novel statistical methodologies as appropriate for clinical studies
• Act as the primary contact and provide oversight for all biometrics related activities outsourced to CROs and external vendors. Work collaboratively with CRO vendors, Clinical Research, Drug Safety, Regulatory, Clinical Operation, and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
• Apply knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objectives
• Develop SOPs for Biostatistics with collaboration with cross-functional teams
• Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company
• Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed 
• Prepare and/or review detailed Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of clinical study report
• Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications
• Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
• Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies
• Conduct hands-on exploratory analyses, sample size computation, modeling and simulation, and create tools to gain meaningful insights from trial data as needed
• Interpret, summarize, and present data and statistical considerations to internal study team, senior management, advisory boarding meetings and global health authorities
• Develop and maintain all biostatistics related SOPs and guideline documents
• Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance
• Ability to work within a team as well as independently
• Provide leadership and direction for department strategic initiatives 
• Effectively interact with Head of Biometrics, Senior Management and Human Resources to identify and justify resource needs, develop staffing plans, manage recruiting process within Biometrics 

Education and Experience:

• PhD degree in Biostatistics or equivalent with 8+ year (or MS degree with 12+ years) of experience in the statistical analysis of biomedical data using statistical software
• Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceutical/biotechnology industry
• Proven competencies in interaction with health authorities (such as FDA, EMA, PMDA) and eCTD (NDA/BLA) regulatory submissions
• Experience working in a quality regulated environment with a thorough understanding of GCPs 
• Extensive hands-on experience in oncology drug development including design and analysis of early and late phase oncology trials
• Excellent programming skills in SAS/R
• Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
• Good understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company
• Demonstrated effective verbal and written communication skills and interpersonal skills
• Makes effective decisions with limited information
• Ability and interest to work cross functionally
• Has strong networks developed that influence collaborations with external academic or government organizations to extend visibility or business need of the company
• Effectively uses competitive intelligence to influence clinical development strategies
• Proven effective interpersonal skills to create collaborative relationships within the function as well as with all cross functional organizations
• Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home). 

Salary: $200,000-$240,000 DOE

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

• Provides operational expertise at the Project level for one or more programs, in conjunction with the head of Operations
• Leads and provides direction to Study Management Teams (SMT).
• Delegates and provides guidance/mentorship to Clinical Trial Managers and/or Clinical Program Associates.
• Identifies program risks, and proactively create sand implement mitigation strategies
• Leads the identification and selection of appropriate CROs and third-party study vendors, and ensures appropriate cross-functional input is included in the scope of work
• Leads and oversees performance of CROs, 3rd party vendors to ensure compliance with study protocol and in accordance with scope of work, escalating as needed
• Contributes or leads the development of clinical protocols, amendments, informed consent forms, study guides, lab manuals, case report forms, study plans and any other clinical research related documents, in collaboration with cross-functional team members or CRO partners
• Establishes and maintains good working relationships with investigators and study staff
• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Creates and manages program and study timelines, including study team goal and milestone creation, and monitoring progress
• Identify program risks, and proactively create and implement mitigation strategies
• Analyzes the feasibility data received from the CRO and makes decisions for the strategic country and site distribution and patient numbers
• Collaborates with Vendor Management in creating and managing study finances, including but not limited to, budget creation, negotiation and maintenance, invoice and payment management
• Collaborates with Data Management to oversee data quality issues (query and data quality management and resolution)
• Reviews key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determines appropriate action in conjunction with study team
• Develop relationships with key thought leaders to support product development and represent ALX Oncology externally in applicable scientific and medical forums
• Oversees CRO TMF management and maintenance checks
• Identify and develop best practices
• Domestic and/or international travel may be required up to 25%

• BA/BS in a relevant scientific discipline or equivalent combination of education/experience in science or health-related field required
• Minimum 8 years clinical trial leadership experience (10 years preferred) in the pharmaceutical industry or equivalent; oncology experience is highly desirable
• Strong leadership and motivational skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies
• Applies critical thinking and aims to simplify work.
• Experienced in developing and executing plans including but not limited to study goal, milestone and risk management plans.
• Must have experience creating and managing complex study budgets, with a focus on financial management of vendors
• Strong vendor management experience, from selection to management, and issue escalation. Experience developing scope of work, and ensuring adherence to it
• Strong understanding of GCP/ICH guidelines and the clinical development process
• Strong influencing, negotiation and conflict resolution skills to build relationships internally and externally at all levels of seniority, and achieve alignment and commitment to deliverables
• Self-motivated, critical thinker, and able to work with minimal oversight
• Detail oriented with the ability to work independently and manage multiple competing priorities under pressure
• Excellent oral and written communication skills and proficient computer skills
• Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).
• Must show proof of full COVID-19 vaccination to attend onsite at our South San Francisco office.

• Providing dynamic regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, external contractors, vendors and consultants to identify optimum and effective regulatory strategies for assigned projects.
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents and stay abreast of the regulatory and competitive landscape.
• Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
• Monitor and analyze regulatory agency activities in areas of interest to the company and assess potential impact on development programs. Take a global view of regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
• Prepare and lead teams through successful regulatory meetings and interactions.
• Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals.
• Lead assigned department initiatives and seek opportunities to foster interdepartmental collaboration.
• Build positive professional relationships and trust with team mates, collegues and regulatory authority contacts.
• Assist in organization and management of staff in the RA group, including coaching, career development and oversight of work.

• Bachelors degree in life sciences; masters or advanced degree desirable.
• 10+ years Regulatory Affairs experience in the biopharmaceutical industry or equivalent.
• Extensive knowledge of regulatory requirements and early to late-stage experience with US, EU, RoW regulatory submissions for therapeutic products and IVDs (IDE/IND/CTA/510K/PMA/BLA /NDA, etc) in eCTD format.
• Ability to develop, understand and implement complex development strategies in the field of oncology.
• Demonstrated successful track record of interacting with regulatory health authorities and effectively moving products through the development process.
• As a member of interdisciplinary teams, ability to successfully manage multiple project deliverables, with ability to function independently in management of critical biopharmaceutical programs.
• Ability to create and manage detailed timelines and track regulatory activities across disciplines and territories.
• Experience in Pediatric, Orphan Drug, Fast Track and Breakthrough Therapy, etc. development and understanding of US, EU and RoW regulations related to these regulatory pathways.
• Prior experience in other key functional areas, (e.g., research, toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics).
• Strong interpersonal skills and excellent oral / written communication skills.
• Highly responsible, self-motivated professional.
• Strong leadership skills that include a desire for accountability.
• Highly collaborative working style with the ability to influence others.
• Superior work ethic that includes working autonomously with an appropriate sense of urgency and accuracy.
• Entrepreneurial orientation with the ability to effectively operate in a dynamic environment.
• Ability to problem-solve on complex issues, often in a cross-functional team setting.
• Prior experience managing direct reports, including coaching and career development.
• Excellent organizational skills that enable the successful execution of multiple simultaneous projects.
• Self-motivated, self-disciplined, and able to function independently, and in a team environment.
• High energy, enthusiasm and passion for the work.
• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.
• Must show proof of full COVID-19 vaccination to attend onsite at our South San Francisco office

• Lead / manage all aspects of CMC regulatory strategy development for ALX’s products (early- to late-stage/registration/post-market).
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents.
• Identify and assess regulatory risks / critical-path activities associated with ALX’s CMC development programs and work to identify regulatory strategies to mitigate risks.
• Problem-solve in a collaborative manner to mitigate risks.
• Monitor and analyze regulatory agency activities with regard to CMC development and assess potential impact on the ALX development programs and stay abreast of the regulatory                  landscape.
• Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.              
• Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation.
• Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals.
• Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons.
• Lead global CMC regulatory submission development - Responsible for planning, coordinating and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).
• Serve as Regulatory Lead for CMC-focused FDA and EU and RoW Scientific Advice meetings. · Review and provide comments on change controls, SOPs, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures, and other related CMC documents.
• Provide timely and transparent communication to team/stakeholders to ensure appropriate cross-functional communication. Regularly communicate project status including expectations, opportunities and risks via written communication, presentations, discussions and informal interactions, as appropriate.
• Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
• This position may require periodic travel (domestic/international).

• Bachelor’s degree (or equivalent) in life sciences, masters or advanced degree preferred.
• 10+ years working within the biotech/pharmaceutical industry.
• 8+ years of pharma and/or biotech regulatory CMC-experience with a demonstrated track record of regulatory success and increasing levels of responsibility.
• Extensive understanding and knowledge of large molecule biologics manufacturing and analytical development validation.
• Extensive knowledge of cGMP, CMC regulatory requirements in the US, EU and RoW.
• Ability to lead matrixed teams, drive and influence effective collaborations. · Sharp critical thinking/problem solving skills.
• Capable of managing multiple projects, excellent time management skills.
• Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.
• Self-motivated, self-disciplined, and able to function independently as well as part of a team.
• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.
• Must show proof of full COVID-19 vaccination to attend onsite at our South San Francisco office