Job Description

General Summary:

We are seeking an accomplished and strategic leader to serve as Executive Director, Biotherapeutics DMPK-Bioanalysis (DMPK-BA), to guide the DMPK-BA strategy for our rapidly growing Biotherapeutics portfolio that includes protein, antibody, ADC, and cell and genetic therapies. The responsibilities will span from early research through development. This leader will be based in Boston but manage and oversee the work of DMPK-BA teams at our Vertex Biologics and Cell and Genetic Therapies sites in Boston and Seattle and will be part of the Global DMPK leadership team. He/she will play a central role in integrating PK, bioanalysis, ADME, and translational PKPD data and insights into cross-functional program decision-making and development plans and help shape the direction of overall Vertex portfolio.

The ideal candidate will bring deep strategic and scientific expertise in DMPK-BA for one or more biotherapeutic modalities described above, have demonstrated record of people management and leadership in a direct line as well as matrixed environment, and will have the ability to influence cross-functional teams and governance bodies at Vertex.

Key Responsibilities

• Develop vision, strategy, and capabilities for the Biotherapeutics DMPK-BA teams across Boston and Seattle sites that is aligned with the Global DMPK-BA and Vertex R&D vision/mission.
• Develop and execute DMPK-BA scientific strategies from discovery through clinical development including design, execution, and interpretation of preclinical PK, ADME, bioanalytical and immunogenicity assays for biotherapeutics, and translational PKPD approaches to support dose selection and clinical projections.
• Provide clear communication of DMPK-BA findings, implications, and recommendations to team members, senior leadership, and Vertex R & D governance bodies to advance Vertex programs through discovery and development.
• Build and maintain strong collaborative partnerships with Biology, Preclinical Safety, Clinical Pharmacology, CMC, and other R & D disciplines to align DMPK-BA strategy with overall program goals.
• Implement innovative technologies and approaches to enhance scientific impact and/or efficiencies.
• Provide scientific and managerial leadership to the team in prioritizing and executing on key deliverables and project needs.
• Ensure scientific excellence and regulatory compliance in all necessary DMPK regulatory documents and reports to support drug development including investigator brochures, INDs (or equivalent), and marketing applications.
• Hire, develop, manage, and retain key talent to maintain a high-performing team.
• Develop internal and external sourcing strategies and liaise across sites to best meet project needs. Contribute to developing Global DMPK-BA resource allocation, staffing needs, expenses, and capital budget and implementation plans.
• Participate in review of business development opportunities.

Qualifications

• PhD in Pharmacokinetics, Biochemistry, Biology, or related field, with 15+ years of industry experience at the management level
• Successful track record and experience managing DMPK-BA teams across more than one therapeutic area. Extensive experience working with one or more biotherapeutic modalities (e.g., protein, antibody and nucleic acid therapeutics, cell and gene therapies) is a must.
• Deep scientific and strategic expertise in various components of DMPK science such as PK, ADME, bioanalysis, immunogenicity, biotransformation, and translational PKPD modeling approaches for biologics.
• Excellent communication skills and ability to develop and grow strong cross-site/function collaborations.
• Ability to critically evaluate and implement new science and technology as it relates to the discovery and development of new medicines.
• Experience preparing regulatory submissions and interacting with health authorities.
• Strong management and leadership skills, with emphasis on developing and mentoring emerging talent.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will 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.

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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 [email protected]