Executive Director, Head of Pharmacovigilance

About the position

TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an Executive Director, Head of Pharmacovigilance to support the execution of our oncology studies in solid tumors and in hematological cancers. The ideal candidate should have relevant experience in oncology, ideally with a cell therapy product, and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

Responsibilities

• Provide medical safety expertise and act as the medical safety lead for TScan clinical studies
• Review safety reports from the PV vendor, including conducting initial triage and causality assessments, generating and resolving queries, and following up with the PV vendor and sites as needed
• Chair internal safety meetings such as the Safety Management Team meeting
• Participate in study safety meetings such as DSMBs, Dose Escalation meetings, PI calls, etc
• Review and approve safety sections of clinical documents (e.g. protocol, ICFs, IBs, Reference Safety Information, etc)
• Lead and contribute to signal detection and analyses of similar events activities to identify potential risks
• Lead the development, implementation and execution of a Risk Management Plan
• Work with the internal team to respond to inquiries from regulatory agencies
• Work with QA and consultants to develop necessary PV SOPs
• Manage direct report(s)

Requirements

• MD (or equivalent) or PharmD required
• 8 - 10 years of experience managing PV activities in oncology clinical studies, preferably with experience in cell therapy studies
• Excellent oral and written business communication skills and ability to work in a flexible, matrix environment
• Knowledge of drug discovery and development program management from Phase 1 registrational studies
• Advanced working knowledge of all relevant guidelines, including ICH, GCP, and relevant PV regulations
• Experience using PV databases (e.g Argus and Veeva) and medical coding systems such as MedDRA
• Experience managing direct reports
• Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders