Medical Director, Pharmacovigilance (Biotech)

TL;DR

Medical Director, Pharmacovigilance (Biotech): Lead global safety strategy and surveillance for allogeneic CAR T cell therapies in cancer and autoimmune diseases with an accent on signal detection, benefit-risk evaluation, and risk management activities. Focus on analyzing safety data from clinical and post-marketing sources, developing risk mitigation strategies, and ensuring compliance with global regulations.

Location: Hybrid in South San Francisco, CA. Remote candidates will be evaluated based on suitability and ability to travel to HQ. Candidates must be authorized to work in the U.S.

Salary: From $250,000 to $335,000 per year

Company

Clinical-stage biotechnology company pioneering off-the-shelf allogeneic CAR T cell (AlloCAR T) products for cancer and autoimmune disease.

What you will do

• Manage pre- and post-marketing safety surveillance activities in compliance with ICH, FDA, EMA, and global GVP regulations.
• Lead global safety strategy, reviewing pre-clinical, clinical, and post-marketing data to maintain positive benefit-risk profile for AlloCAR T therapies.
• Collaborate with Biostatistics, Clinical, Translational Sciences, Research, and Regulatory Affairs to identify, evaluate, and mitigate safety signals.
• Provide clinical safety support for development programs, author safety sections in protocols, Investigator's Brochures, ICFs, and study reports.
• Develop safety data collection standards, respond to health authority queries, and lead preparation of high-quality safety reports.
• Perform medical review of individual case safety reports (ICSRs) for timely regulatory submissions.

Requirements

• Medical degree (MD) with strong clinical background and at least 3 years of relevant industry experience
• 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, critical thinking, communication, and organizational skills
• Must be authorized to work in the U.S.

Nice to have

• Experience in clinical practice or clinical research
• Experience in oncology and/or cell therapy

Culture & Benefits

• Collaborative environment with talented people in cell therapy.
• Top-notch compensation including annual performance bonus and equity.
• Health insurance, generous time off, and 2 annual company-wide holiday shutdowns.

Hiring process

• Standard interviews evaluating experience, qualifications, and fit for the role.