Job Description
General Summary:
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 Toxicology Disease Area Lead (TDAL) leads PSA’s support for a specific Disease Area [DA] (e.g., VCGT, Pulmonary, Renal or Pain) from VXc enabling activities to Registration & LOE. The TDAL is accountable for the development and implementation of the preclinical safety and risk management strategies within their designated DA, ensuring the strategy is aligned with the overall objectives of the DA, and enabling the DA-goals to be met. In addition, as a member of DA specific governance bodies, the TDAL will contribute drug development and safety expertise to DA discussions.
The TDAL reports to the PSA Portfolio Head.
Key Duties & Responsibilities:
- Point of accountability for the development and delivery of a comprehensive preclinical safety strategy for programs within their designated DA.
- Line or matrix leader ensuring PSA portfolio resources (project reps or study monitors) are effectively deployed to support programs within their designated DA, and management/resolution of safety issues
- Provide ongoing guidance and mentorship to PSA portfolio reps and study monitors working on programs within the TDALs designated DA (VXc-LOE)
- Ensures delivery of PSA components of stage gate documentation, Nonclinical Overviews (NCOs), Investigator Brochures (IBs), etc. through global registration.
- Reviews and endorses regulatory responses and participates in Regulatory Agency interactions, as required for programs within their designated DA.
- Applies the breath/depth of scientific expertise to develop integrated safety perspectives to successfully address program issues and support project decisions that differentiate Vertex from its competitors.
- Drive organizational and regulatory acceptance of innovative scientific approaches/thinking and regulatory packages to accelerate program deliverables in close collaboration with research & development leads, project teams and PSA leadership
- Can act as a program rep for projects assigned by the PSA Portfolio Head.
- Forge 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.
- Perform all regulatory responsibilities in compliance with applicable regulatory standards.
- Review and endorse Issues Management Plans for programs within their designated DA.
- Ensure PSA resources are aligned with DA objectives and priorities
- Ensures that PSA expertise is applied to potential licensing or acquisition deals within designated DA.
- Lead the development of new or innovative solutions to meet business needs and enhance the company’s research productivity or competitive advantage.
- Participation in regulatory submission document preparation, poster presentations and scientific publications, including addressing queries from global health authorities
- Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of these findings to human safety.
- Extended Team member of the PSA-LT
Education and Experience:
- Ph. D., and/or DVM or equivalent
- 10+ 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”
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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.