Job Description
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" #LI-KM4 Pay Range:
$280,000 - $420,000 Disclosure 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 Eligible Flex 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 select 2. 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-Hybrid Company Information Vertex 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 ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives. Our vision is clear:
to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
