Head of Exploratory and Regulatory Safety Sciences
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Key Duties & Responsibilities:
- Provide nonclinical regulatory strategy leadership, oversight, and advice for Vertex preclinical safety and risk management across discovery to registration and loss of exclusivity.
- Advance regulatory acceptance of innovative scientific approaches; promote regulatory packages to accelerate portfolio deliverables.
- Serve as subject matter expert in nonclinical and late-stage development/registration for small molecules, biologics, cell therapies, and other novel modalities.
- Lead matrix activities across the preclinical safety assessment (PSA) organization; ensure regulatory responsibilities comply with applicable standards.
- Contribute to issues management plans; participate in regulatory submission documents, posters, publications, and responses to global health authority queries.
- Resolve toxicological issues and assess relevance to human safety.
- Act as a Toxicology Disease Area Lead (TDAL); participate in PSA leadership/extended team.
- Develop next-generation PSA ERSS leaders; manage ERSS resource allocation and external influencing; lead external engagement (e.g., consortia).
Required Education & Experience:
- Ph.D. and/or DVM (or equivalent)
- 15+ years preclinical safety R&D in pharma/biotech
- Expertise in preclinical development and deep understanding of FDA/EMA/ICH guidance and international GLP
Required Skills:
- Strong analytical/problem-solving; lead troubleshooting in preclinical development
- Excellent communicator/influencer; strong writing and persuasion
- Ability to make high-quality decisions in ambiguity
- Proven success partnering/influencing senior leaders; experience in highly matrixed organizations
Pay Range:
- $280,000 - $420,000
- Provide nonclinical regulatory strategy leadership, oversight, and advice for Vertex preclinical safety and risk management across discovery to registration and loss of exclusivity.
- Advance regulatory acceptance of innovative scientific approaches; promote regulatory packages to accelerate portfolio deliverables.
- Serve as subject matter expert in nonclinical and late-stage development/registration for small molecules, biologics, cell therapies, and other novel modalities.
- Lead matrix activities across the preclinical safety assessment (PSA) organization; ensure regulatory responsibilities comply with applicable standards.
- Contribute to issues management plans; participate in regulatory submission documents, posters, publications, and responses to global health authority queries.
- Resolve toxicological issues and assess relevance to human safety.
- Act as a Toxicology Disease Area Lead (TDAL); participate in PSA leadership/extended team.
- Develop next-generation PSA ERSS leaders; manage ERSS resource allocation and external influencing; lead external engagement (e.g., consortia).
Required Education & Experience:
- Ph.D. and/or DVM (or equivalent)
- 15+ years preclinical safety R&D in pharma/biotech
- Expertise in preclinical development and deep understanding of FDA/EMA/ICH guidance and international GLP
Required Skills:
- Strong analytical/problem-solving; lead troubleshooting in preclinical development
- Excellent communicator/influencer; strong writing and persuasion
- Ability to make high-quality decisions in ambiguity
- Proven success partnering/influencing senior leaders; experience in highly matrixed organizations
Pay Range:
- $280,000 - $420,000