Medical Director, Pharmacovigilance

About AllogeneAllogene 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 RoleReporting 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 ToManage 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 stakeholdersCollaborate 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 signalsProvide clinical safety support and input for clinical development programsParticipate 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 communicationParticipate in the development of safety-related data collection standards for clinical studies to ensure consistency in safety data collectionCollaborate on the strategy and authoring of health authority and other safety related query responsesProvide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reportsMedical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authoritiesDemonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH)Other duties as assignedPosition Requirements & ExperienceMedical degree (MD) with a strong clinical background, with at least 3 of relevant years industry experienceExperience in clinical practice or clinical research is preferredExperience in oncology and/or cell therapy is strongly preferredThorough understanding of pharmacovigilance principles, global regulatory requirements, and MedDRA codingExperience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trialsMust be proficient in ArgusExcellent analytical and critical thinking skills to evaluate complex medical dataStrong communication and collaboration skills to effectively interact with cross-functional teamsExcellent 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 teamAbility to communicate with internal and external physicians to evaluate specific safety eventsCandidates must be authorized to work in the U.SWe 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.