Executive Director, Pharmacovigilance

My client is a clinical-stage bio pharmaceutical company dedicated to transforming cancer treatment through the development of T cell receptor (TCR)-engineered therapies. They are seeking their first Pharmacovigilance professional to come in as an Executive Director, Head of Pharmacovigilance to lead safety oversight for their oncology clinical programs, including both solid tumors and hematologic malignancies. The ideal candidate will bring deep expertise in oncology pharmacovigilance-preferably with experience in cell therapy-and thrive in a fast-paced, collaborative start-up environment. A proactive, team-oriented leader with a strong sense of urgency will excel in this role.

Key Responsibilities

Medical Safety Leadership

• Serve as the medical safety lead for the company's clinical trials, providing expert guidance on safety strategy and execution.
• Review safety reports from pharmacovigilance vendors, including triage, causality assessments, query resolution, and follow-up with vendors and clinical sites.
• Chair internal safety meetings, including the Safety Management Team.
• Participate in external safety-related meetings such as DSMBs, dose escalation meetings, and investigator calls.

Clinical Document Review

• Review and approve safety-related sections of clinical documents, including protocols, informed consent forms (ICFs), Investigator's Brochures (IBs), and Reference Safety Information.

Signal Detection & Risk Management

• Lead signal detection activities and analyses of similar events to identify emerging safety risks.
• Develop, implement, and oversee Risk Management Plans (RMPs) to proactively manage product safety.

Regulatory & Compliance Support

• Collaborate with internal teams to prepare responses to regulatory agency inquiries.
• Partner with Quality Assurance and external consultants to develop and maintain PV standard operating procedures (SOPs).

Team & Vendor Management

• Manage and mentor direct reports within the PV function.
• Oversee vendor relationships to ensure high-quality safety data and compliance with regulatory expectations.

Qualifications

• MD (or equivalent) or PharmD required.
• 8-10 years of pharmacovigilance experience in oncology clinical trials, with preference for cell therapy experience.
• Strong understanding of drug development across all phases, from Phase 1 through registration.
• In-depth knowledge of global PV regulations and guidelines, including ICH, GCP, and FDA requirements.