Sr. Director, Safety & Pharmacovigilance

Summary

Responsibilities

• Serve as the safety subject-matter expert for cell therapy programs for MS, MG and other indications as needed, including novel and emerging risks.
• Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions.
• Act as a key member of cross-functional governance and program teams.
• Oversee all medical safety activities including individual case assessment, signal detection, risk management, and aggregate reporting for assigned indications or products.
• Lead safety surveillance activities and ongoing benefit-risk assessments.
• Review and approve safety data, medical assessments, and regulatory safety documents.
• Contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and internal safety governance forums for assigned products or indications.
• Lead safety signal evaluation, escalation, and documentation.
• Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities).
• Partner with team lead for regulatory interactions, inspections, and audits.
• Author or oversee safety sections of INDs and BLAs, and responses to health authority inquiries for assigned products or indications.
• Partner with team members to maintain PV SOPs, processes, and inspection readiness.
• Proactively identify and mitigate safety risks associated with cell therapy modalities.
• Contribute to the operational excellence, continuous improvement of the GSP department’s initiatives.

Qualifications

• MD degree
• 8+ years of experience in pharmacovigilance and drug safety, with at least 3 years in a leadership role.
• Direct experience supporting cell therapy, gene therapy, or experience with autoimmune or CNS indications, such as MS or MG strongly preferred.
• Experience in clinical-stage biotech; prior BLA/MAA and/or launch experience is a plus.
• Demonstrated success interacting with global regulatory agencies on safety matters.
• Strong knowledge of global PV regulations and safety standards.
• Strategic thinker with the ability to operate hands-on in a lean organization.
• Excellent cross-functional leadership and communication skills.
• Proven ability to balance compliance, scientific rigor, and business priorities.

Additional information