Executive Director, Biotherapeutics DMPK

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.