Head of Exploratory and Regulatory Safety Sciences

Job Description

PSA is a global function responsible for the nonclinical safety strategy for the Vertex portfolio & therapies at all stages of discovery and development. Vertex Pharmaceuticals uses cutting edge science, technology, and novel therapies for the treatment of the most serious diseases with unmet medical need. The Exploratory and Regulatory Safety Sciences (ERSS) head leads a major functional area within PSA and plays a pivotal role in the development and implementation of the preclinical safety and risk management strategies for the Vertex portfolio (small molecule & VCGT) from VXc, FIH to Registration and loss of Exclusivity (LoE), ensuring that the PSA safety strategy enables Vertex goals.

Key Duties & Responsibilities:

• A nonclinical global regulatory expert in nonclinical toxicology and regulatory guidelines
• Accountable for providing nonclinical regulatory strategy leadership, oversight, and advice across the organization to achieve Vertex’s goals
• Advances regulatory acceptance of innovative scientific approaches and insight
• Deep understanding of drug development approaches
• Promotes regulatory packages to accelerate portfolio deliverables
• A subject matter expert in nonclinical and late-stage development and registration for small molecules, biologics, cell therapies and other complex novel modalities
• Matrix leader across the preclinical safety assessment (PSA) organization with in-depth understanding of preclinical sciences and its relevance to drug discovery and clinical development
• Performs all regulatory responsibilities in compliance with applicable regulatory standards
• Contributes to and aligns with Issues Management plans for the portfolio
• Participates in regulatory submission document preparation, poster presentations and scientific publications, including addressing queries from global health authorities
• Addresses and resolves toxicological issues arising in drug development programs and adequately assess the relevance of these findings to human safety
• A Toxicology Disease Area Lead (TDAL) for one or more disease areas
• A member of the PSA leadership team and Extended Team member of the PCS-LTE
• Forges strong partnerships (within discipline, other nonclinical and clinical lines) and build credibility to shape senior leader thinking on safety issues and collaborate internally and externally to deliver on functional/departmental/Vertex goals
• Responsible for the development of the next generation of PSA ERSS leaders
• Accountable for ERSS resource allocation and external influencing
• Leads Vertex engagement in the external environment such as consortia (IQ etc.)

Required Education & Experience:

• Ph. D., and/or DVM or equivalent
• 15 years of experience of preclinical safety research and development in the pharma/biotech industry
• Expertise in preclinical development for small molecules and biologic/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 in depth understanding of GLP guidelines internationally
• Highly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific vision
• Strong analytical and problem-solving skills; expected to lead troubleshooting in all areas of preclinical development
• Documented success in partnering/influencing other senior leaders to ensure alignment of issue resolution strategies across enterprises
• Makes good scientific and regulatory decisions based on a mixture of analysis, wisdom, experience, and judgment
• Can make high quality decisions in an ambiguous environment, e. g. without access to all the data
• A problem solver, pragmatist, and an excellent communicator/influencer
• Highly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific vision
• Experience leading within a highly matrixed organization. Highest work ethic and professional integrity; proactive, dynamic and “hands on”