Executive Director, Biotherapeutics DMPK

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 268,000 - 402,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated seeks an Executive Director, Biotherapeutics DMPK-Bioanalysis (DMPK-BA) to guide strategy for a growing Biotherapeutics portfolio, spanning protein, antibody, ADC, and cell/gene therapies. Based in Boston, this leader will coordinate DMPK-BA teams in Boston and Seattle and integrate PK, bioanalysis, ADME, and translational PKPD into program decisions.

The role requires 15+ years of senior DMPK experience, strong cross-site leadership, regulatory submission

Qualifications

• PhD in Pharmacokinetics, Biochemistry, Biology or related field with 15+ years leadership experience.
• Proven experience leading DMPK-BA teams across multiple therapeutic areas.
• Deep expertise in PK, ADME, bioanalysis, immunogenicity and translational PKPD for biologics.
• Excellent communication and cross-site collaboration.
• Experience in regulatory submissions and health authority interactions.
• Strong management, mentoring, and talent development.
• Ability to evaluate and implement new science and technology.

Responsibilities

• Develop vision, strategy, and capabilities for Biotherapeutics DMPK-BA teams across Boston and Seattle.
• Lead design, execution, and interpretation of preclinical PK, ADME, bioanalytical and immunogenicity assays.
• Communicate DMPK-BA findings to senior leadership and governance bodies to advance programs.
• Build partnerships with Biology, Preclinical Safety, Clinical Pharmacology, CMC, and other R&D teams.
• Implement innovative technologies to enhance impact and efficiency.
• Provide scientific and managerial leadership to prioritize and deliver key milestones.
• Ensure regulatory documentation complies with applicable standards and regulations.
• Hire, develop, and retain key talent to maintain a high-performing team.
• Manage global DMPK-BA resource allocation and budgeting.
• Participate in business development review where applicable.

Skills

Leadership

Strategic thinking

Cross-site collaboration

Regulatory experience

Scientific communication

Mentoring

Innovation assessment

Education

PhD in Pharmacokinetics/Biochemistry/Biology

Job description

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.

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.

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

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.

#LI-Onsite

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 [e-mail]