Senior Director, Safety & Pharmacovigilance

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the safety subject-matter expert for cell therapy programs related to MS, MG, and other relevant indications, encompassing novel and emerging risks.

• Provide strategic safety insights to clinical development plans, protocols, investigator brochures, and regulatory submissions.

• Serve as a vital member of cross-functional governance and program teams.

• Supervise medical safety activities, including individual case evaluation, signal detection, risk management, and aggregate reporting.

• Lead safety surveillance efforts and ongoing benefit-risk evaluations.

• Review and authorize safety data, medical assessments, and regulatory safety documents.

• Collaborate in Safety Review Committees, Data Monitoring Committees, and internal safety governance forums.

• Direct safety signal evaluation, escalation, and documentation processes.

• Ensure adherence to global safety regulations, including FDA, EMA, ICH, CIOMS, and local health authorities.

• Collaborate with the team lead for regulatory interactions, inspections, and audits.

• Write or oversee the safety sections of INDs and BLAs, as well as responses to inquiries from health authorities.

• Work with team members to uphold pharmacovigilance SOPs, processes, and inspection readiness.

• Proactively identify and mitigate safety risks associated with cell therapy modalities.

• Contribute to operational excellence and continuous improvement efforts within the GSP department.

⛳️ Requirements

• MD degree.

• Over 12 years of experience in pharmacovigilance and drug safety, with a minimum of 5 years in a leadership position.

• Direct experience in supporting cell therapy, gene therapy, or familiarity with autoimmune or CNS indications, such as MS or MG, is strongly preferred.

• Experience in clinical-stage biotechnology.

• Previous BLA/MAA and/or launch experience is advantageous.

• Proven success in interacting with global regulatory agencies on safety issues.

• Strong understanding of global pharmacovigilance regulations and safety standards.

• Ability to work hands-on in a lean organizational structure.

• Exceptional cross-functional leadership and communication capabilities.

• Proven skill in balancing compliance, scientific rigor, and business priorities.

🏝️ Benefits

• Bonus eligibility.

• Comprehensive benefits package.

• Participation in the company’s stock plan.