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:
$268,000 - $402,000

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.

Flex Designation:
On-Site Designated

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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