Medical Director, Pharmacovigilance

Job Description


About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

About the role:

Reporting to the VP, Pharmacovigilance, the Medical Director, Pharmacovigilance serves as the safety expert accountable for the global safety strategy and overall safety profile throughout a product's lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. You will help develop and lead surveillance activities and provide scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature and other information sources. You will focus on the proactive identification, evaluation, and risk management of safety risks to patients.

Responsibilities include, but are not limited to:

• Manage all pre- and post-marketing safety surveillance activities throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP)
• Lead and provide input to global safety strategy ensuring review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for Allogenic CAR T therapy in collaboration with essential stakeholders
• Collaborate with other functional areas, including but not limited to Biostatistics, Clinical, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and develop risk management strategies for safety signals
• Provide clinical safety support and input for clinical development programs
• Participate in the authoring of relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication
• Participate in the development of safety-related data collection standards for clinical studies to ensure consistency in safety data collection
• Collaborate on the strategy and authoring of health authority and other safety related query responses
• Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
• Medical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authorities
• Demonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH)
• Other duties as assigned

Position Requirements & Experience:

• Medical degree (MD) with a strong clinical background, with at least 3 of relevant years industry experience
• Experience in clinical practice or clinical research is preferred
• Experience in oncology and/or cell therapy is strongly preferred
• Thorough understanding of pharmacovigilance principles, global regulatory requirements, and MedDRA coding
• Experience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials
• Must be proficient in Argus
• Excellent analytical and critical thinking skills to evaluate complex medical data
• Strong communication and collaboration skills to effectively interact with cross-functional teams
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
• Ability to communicate with internal and external physicians to evaluate specific safety events
• Candidates must be authorized to work in the U.S

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $255,000 to $335,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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