Vice President, Drug Safety and Pharmacovigilance
City Therapeutics · Cambridge · $385,000–$405,000 (stated in the posting)
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.
Responsibilities
- 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 vendor adherence to regulatory requirements, contractual obligations, timelines, and quality standards.
- Monitor changes in global pharmacovigilance regulations and industry standards, lead gap assessments, and implement necessary process improvements.
- Build and develop the pharmacovigilance organization as the portfolio advances, including workforce planning, talent development, and succession planning.
- Foster a culture of scientific rigor, collaboration, accountability, urgency, and commitment to patient safety.
Qualifications
- MD or equivalent medical degree required.
- Board certification or relevant postgraduate clinical training is strongly preferred.
- A 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.
- Experience in a biotechnology or start-up environment is strongly preferred.
- Experience with RNA therapeutics or therapeutic areas relevant to City Therapeutics’ pipeline is a plus.
Our Working Model: In Person, By Design
At City, we believe that science and culture thrive together, and that happens best in person. Our working model is clear: we work onsite at our Kendall Square offices five days per week. This choice reflects our belief that great science and cultures run on connection, fairness, and growth.
- Connection: Face time matters. Building an enduring biotech company is about people, science, and strategy. Working side by side sharpens ideas, accelerates feedback, and fuels innovation for patients.
- Fairness: One model for all. Every voice counts, and fairness depends on shared experience. We hold ourselves to one standard across all levels and functions.
- Growth: Learning moves faster in person. Growth comes from conversation, observation, and mentorship. We believe in developing talent, and that happens best when we are together.
- We also know that life is not always predictable. When individual needs arise, we are flexible and supportive and work together to balance home life with life at City.
- We believe diverse teams drive better science. We welcome applicants from all backgrounds and experiences who share our mission to bring transformative RNAi medicines to patients.
Compensation The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Pay range is $385,000-$405,000
City Therapeutics is an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration without regard to race, color, religion, national origin, gender, gender identity or expression, sexual orientation, age, disability, veteran status, or any other characteristic protected by law.
City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment Agency submissions will not be accepted at this time.
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