Head of Exploratory and Regulatory Safety Sciences

Vertex Inc.•Boston, MA

7d•$280,000 - $420,000•Hybrid

About The Position

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.

Requirements

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”

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.)