Vice President, Head of Safety and Pharmacovigilance
Location: Remote in South San Francisco, CA
Type: Full Time
Salary Range: From $320,000 to $380,000 per year
About Allogene
Allogene Therapeutics, headquartered in South San Francisco, is a pioneering clinical-stage biotechnology company focused on developing allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune diseases. Our management team has extensive experience in cell therapy, and we are committed to delivering readily available, "off-the-shelf" CAR T cell therapies to more patients. Our ongoing trials include cemacabtagene ansegedleucel (cema-cel) for non-Hodgkin lymphoma and chronic lymphocytic leukemia, with additional programs targeting advanced renal cell carcinoma and autoimmune disorders.
About the Role
Reporting directly to the Head of R&D/CMO, the Vice President, Head of Safety and Pharmacovigilance will lead cross-functional efforts across Clinical Development, Regulatory Affairs, and Quality, among others. Remote candidates will be considered based on qualifications, and on-site presence will be negotiated. We encourage skilled applicants to apply.
Key Responsibilities
Leadership: Manage the safety team, providing training, coaching, and performance evaluations to maximize contributions.
Safety Expertise: Serve as the in-house expert for drug safety and pharmacovigilance for product candidates.
Clinical Oversight: Oversee clinical trial safety, including safety monitoring plans and data analysis.
Risk Management: Assess emerging safety data, develop risk communication, and implement risk minimization strategies.
Regulatory Interaction: Lead cross-functional management of interactions with health agencies regarding product candidate safety.
Committee Leadership: Facilitate Safety Review Committee meetings and participate in Data Safety Monitoring Board (DSMB) meetings as necessary.
Strategy Implementation: Develop and implement pharmacovigilance strategies and oversee the authorship of aggregate safety reports (e.g., DSURs, SAE reporting).
Vendor Oversight: Manage safety vendors and ensure compliance with safety oversight and reporting obligations.
Change Leadership: Identify opportunities for alignment and lead necessary changes.
Collaborative Initiatives: Collaborate with functional leaders to set strategies and shared objectives.
Representation: Act as the Safety representative in meetings with regulatory authorities and external partners.
Position Requirements
Education: MD or equivalent degree; completion of residency with industry experience in safety and pharmacovigilance; oncology and/or autoimmune development experience required; cell therapy experience preferred.
Experience: Global experience in clinical trials and post-marketing settings, particularly in oncology/cell therapy; familiarity with global regulatory filings.
Skills: Strong organizational and prioritization skills to deliver results within tight timelines; exceptional interpersonal and communication skills for collaborative environments; knowledge of US, EU, and Asian pharmacovigilance regulations.
Vendor Management: Ability to evaluate CROs and other vendors for safety oversight and reporting.
Work Authorization: Candidates must be authorized to work in the U.S.
What We Offer
Join us to work alongside talented individuals in a collaborative environment. We provide a competitive compensation and benefits package, including an annual performance bonus, equity, health insurance, generous time off (including two company-wide holiday shutdowns), and more.
The expected salary range for this role is $320,000 to $380,000, with actual pay based on experience, qualifications, and geographic location.
Equal Opportunity Employment
Allogene is committed to a diverse workforce. We ensure that employment decisions are made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity, veteran status, or other non-job-related characteristics. We embrace diverse experiences and perspectives, focusing on developing life-changing products for patients.
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