Vice President, Drug Safety and Pharmacovigilance

Cambridge, MA

Vice President, Drug Safety and Pharmacovigilance

City Therapeutics is engineering the future of RNAi-based medicine. Founded by pioneers in RNA interference, we combine next-generation trigger molecule engineering with innovative targeting technologies to expand the reach of RNAi beyond the liver. We are building a diversified research and development pipeline with the goal of creating best-in-class medicines that make a meaningful difference for patients.

Reporting directly to the Chief Medical Officer, the Vice President of Drug Safety and Pharmacovigilance will serve as City Therapeutics’ senior physician safety expert and provide strategic leadership across all pharmacovigilance and drug safety activities.

This executive will be responsible for establishing and leading the company’s global safety strategy, governance, surveillance, reporting, and risk‑management capabilities across its clinical‑stage portfolio. The Vice President will provide medical oversight of safety data, lead benefit‑risk assessments, and ensure that City maintains scalable, compliant, and inspection‑ready pharmacovigilance systems.

The successful candidate will work closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality, Research, and external partners. This role requires exceptional medical judgment, deep safety‑science expertise, and the ability to balance strategic leadership with hands‑on execution in a growing biotechnology company.

• Develop and lead City Therapeutics’ global pharmacovigilance and drug safety strategy in alignment with the company’s clinical development plans and broader corporate objectives.
• Serve as the company’s senior medical authority for safety matters, providing clear, evidence‑based benefit‑risk assessments and recommendations to executive leadership.
• Lead ongoing safety surveillance and signal detection, including signal validation, evaluation, prioritization, communication, and risk mitigation for development‑stage assets.
• Establish and lead Safety Review Committees and other safety‑governance forums at the study, program, and portfolio levels.
• Oversee the preparation, medical review, and approval of aggregate safety reports, including DSURs, PBRERs/PSURs, risk‑management plans, and ad hoc safety assessments.
• Provide expert safety input into clinical protocols, informed consent forms, Investigator’s Brochures, Clinical Study Reports, integrated summaries of safety, development plans, and regulatory submissions.
• Lead the strategy and preparation of responses to regulatory authority inquiries involving safety matters, including the development of appropriate MedDRA search and analysis strategies.
• Provide pharmacovigilance leadership for regulatory filings, health authority meetings, inspections, due diligence activities, and other critical company initiatives.
• Represent Drug Safety and Pharmacovigilance during interactions with the FDA, EMA, MHRA, and other global regulatory authorities.
• Build and maintain fit‑for‑purpose pharmacovigilance policies, procedures, templates, analytics, reporting infrastructure, quality controls, and inspection‑readiness capabilities.
• Oversee individual case safety report processing, expedited reporting, reconciliation activities, and safety database operations.
• Partner with Clinical Development and Biometrics on safety data review, database adjudication, statistical analysis, and interpretation.
• Select, oversee, and manage pharmacovigilance CROs and other external service providers, including performance, quality, contracts, budgets, invoices, and issue resolution.
• Establish and monitor key performance indicators and quality metrics to ensure…