Head of Exploratory and Regulatory Safety Sciences

Job DescriptionPSA 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 guidelinesAccountable for providing nonclinical regulatory strategy leadership, oversight, and advice across the organization to achieve Vertex’s goalsAdvances regulatory acceptance of innovative scientific approaches and insightDeep understanding of drug development approachesPromotes regulatory packages to accelerate portfolio deliverablesA subject matter expert in nonclinical and late-stage development and registration for small molecules, biologics, cell therapies and other complex novel modalitiesMatrix leader across the preclinical safety assessment (PSA) organization with in-depth understanding of preclinical sciences and its relevance to drug discovery and clinical developmentPerforms all regulatory responsibilities in compliance with applicable regulatory standardsContributes to and aligns with Issues Management plans for the portfolioParticipates in regulatory submission document preparation, poster presentations and scientific publications, including addressing queries from global health authoritiesAddresses and resolves toxicological issues arising in drug development programs and adequately assess the relevance of these findings to human safetyA Toxicology Disease Area Lead (TDAL) for one or more disease areasA member of the PSA leadership team and Extended Team member of the PCS-LTEForges 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 goalsResponsible for the development of the next generation of PSA ERSS leadersAccountable for ERSS resource allocation and external influencingLeads Vertex engagement in the external environment such as consortia (IQ etc.)Required Education & Experience:Ph. D., and/or DVM or equivalent15 years of experience of preclinical safety research and development in the pharma/biotech industryExpertise in preclinical development for small molecules and biologic/biotherapeutics and other complex or novel modalitiesDeep understanding of preclinical sciences and its relevance to drug discovery and clinical developmentStrong understanding of FDA, EMA, and ICH regulatory guidance in drug development and in depth understanding of GLP guidelines internationallyHighly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific visionStrong analytical and problem-solving skills; expected to lead troubleshooting in all areas of preclinical developmentDocumented success in partnering/influencing other senior leaders to ensure alignment of issue resolution strategies across enterprisesMakes good scientific and regulatory decisions based on a mixture of analysis, wisdom, experience, and judgmentCan make high quality decisions in an ambiguous environment, e. g. without access to all the dataA problem solver, pragmatist, and an excellent communicator/influencerHighly refined writing skills that complement advanced intellectual contributions, and superior persuasiveness, and/or charisma, for convincing audiences of scientific visionExperience leading within a highly matrixed organization. Highest work ethic and professional integrity; proactive, dynamic and “hands on”#LI-KM4Pay Range:$280,000 - $420,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific innovation. 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. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io: Boston, MAType: Full time