Medical Director, Pharmacovigilance

Allogene Therapeutics•South San Francisco, CA

22h•$255,000 - $335,000•Hybrid

About The Position

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. Ideally this is a hybrid role based at our headquarters in South San Francisco, CA. Remote candidates will be evaluated based on suitability for the position along with ability to travel to HQ.

Requirements

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

Responsibilities

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