Head of Exploratory and Regulatory Safety Sciences
Hybrid · Boston, Massachusetts, United States
Job Summary
Head of Exploratory and Regulatory Safety Sciences (ERSS) leads a major functional area within PSA, driving nonclinical regulatory strategy, safety development, and risk management across Vertex’s portfolio from discovery through registration. The role requires senior-level expertise in preclinical safety for small molecules, biologics, and other modalities, with responsibilities including regulatory strategy leadership, submission support, issue resolution of toxicology findings, cross-functional leadership in a highly matrixed organization, and external engagement. Ideal candidate will have a PhD or DVM (or equivalent) with approximately 15 years of industry experience, deep regulatory knowledge (FDA/EMA/ICH), and exceptional scientific writing and communication skills.
Required Qualifications
- Ph.D., and/or DVM or equivalent
- 15 years of preclinical safety research and development experience in pharma/biotech
- Expertise in preclinical development for small molecules and biologics/biotherapeutics and other complex or novel modalities
- Deep understanding of preclinical sciences and its relevance to drug discovery and clinical development
- Strong understanding of FDA, EMA, and ICH regulatory guidance in drug development and GLP guidelines internationally
- Highly refined writing skills for scientific vision and persuasive communication
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