Head of Exploratory and Regulatory Safety Sciences

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. 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 assesses the relevance of these findings to human safety. Toxicology Disease Area Lead (TDAL) for one or more disease areas. Member of the PSA leadership team and Extended Team member of the PCS‑LTE. Builds strong partnerships within discipline, other nonclinical and clinical lines, and builds credibility to shape senior leader thinking on safety issues and collaborate internally and externally. 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 in 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. Problem solver, pragmatist, and an excellent communicator/influencer. Experience leading within a highly matrixed organization. Highest work ethic and professional integrity; proactive, dynamic and “hands on.” Compensation & Benefits Pay Range: $280,000 – $420,000. Eligible for an annual bonus, annual equity awards, and overtime pay if applicable. Benefits include medical, dental, vision, generous paid time off, educational assistance, student loan repayment, commuting subsidy, matching charitable donations, 401(k) sponsorship, and more. Work Arrangement Hybrid‑Eligible or On‑Site Eligible. Hybrid: work remotely up to two days per week; On‑Site: work five days per week on‑site with ad hoc flexibility. Equal Employment Opportunity Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)