Vice President, Drug Safety and Pharmacovigilance

City Therapeutics is engineering the future of RNAi-based medicine, combining next-generation trigger molecule engineering with innovative targeting technologies to expand the reach of RNAi beyond the liver. Reporting directly to the Chief Medical Officer, the Vice President of Drug Safety and Pharmacovigilance will serve as the company's senior physician safety expert and provide strategic leadership across all pharmacovigilance and drug safety activities. The role covers global safety strategy, governance, surveillance, reporting, and risk management across the clinical-stage portfolio, and requires close work with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality, Research, and external partners. The company works onsite at its Kendall Square offices five days per week. City Therapeutics accepts resumes/CVs from direct applicants only; recruitment agency submissions will not be accepted.

Responsibilities

Develop and lead the company's global pharmacovigilance and drug safety strategy in alignment with clinical development plans and corporate objectives; Serve as the senior medical authority for safety matters, providing benefit-risk assessments and recommendations to executive leadership; Lead safety surveillance and signal detection, including validation, evaluation, prioritization, communication, and risk mitigation; Establish and lead Safety Review Committees and other safety-governance forums; Oversee preparation, medical review, and approval of aggregate safety reports (DSURs, PBRERs/PSURs, risk-management plans, ad hoc safety assessments); Provide expert safety input into clinical protocols, informed consent forms, Investigator's Brochures, Clinical Study Reports, integrated safety summaries, development plans, and regulatory submissions; Lead strategy and preparation of responses to regulatory authority inquiries involving safety matters, including MedDRA search and analysis strategies; Provide pharmacovigilance leadership for regulatory filings, health authority meetings, inspections, and due diligence; Represent Drug Safety and Pharmacovigilance with the FDA, EMA, MHRA, and other global regulators; Build and maintain pharmacovigilance policies, procedures, analytics, reporting infrastructure, quality controls, and inspection readiness; Oversee individual case safety report processing, expedited reporting, reconciliation, 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, and issue resolution; Establish and monitor KPIs and quality metrics for vendor adherence; Monitor changes in global pharmacovigilance regulations, lead gap assessments, and implement process improvements; Build and develop the pharmacovigilance organization, including workforce planning, talent development, and succession planning; Foster a culture of scientific rigor, collaboration, accountability, urgency, and commitment to patient safety

Requirements

MD or equivalent medical degree required; Minimum of 12 years of progressive experience in pharmacovigilance, drug safety, clinical development, or a closely related function within the biotechnology, pharmaceutical, or CRO industry; Significant leadership experience, including responsibility for pharmacovigilance strategy, teams, governance, and outsourced operations; Demonstrated experience building or scaling a pharmacovigilance function within a clinical-stage biotechnology or pharmaceutical company; Deep knowledge of global pharmacovigilance regulations and guidance, including pre- and post-marketing safety requirements in the United States and European Union; Demonstrated expertise in safety surveillance, signal management, aggregate reporting, risk management, and benefit-risk assessment; Strong experience supporting clinical development programs and regulatory submissions, including integrated safety analyses and responses to health authority inquiries; Proven experience leading regulatory authority interactions and supporting successful pharmacovigilance inspections; Experience overseeing CROs, pharmacovigilance service providers, safety databases, and other outsourced operations; Exceptional medical judgment, analytical thinking, scientific writing, and executive communication skills; Demonstrated ability to communicate complex safety information clearly and provide well-supported recommendations to senior leaders and cross-functional teams; Ability to lead effectively in a fast-paced, growing organization while remaining willing to engage directly in critical deliverables

Nice to have

Board certification or relevant postgraduate clinical training; Experience in a biotechnology or start-up environment; Experience with RNA therapeutics or therapeutic areas relevant to City Therapeutics' pipeline

Benefits

Annual bonus; Equity compensation; Competitive benefits package