DMPK Senior Research Fellow - Biotherapeutics

Role Summary

We are seeking an accomplished and strategic leader to serve as Senior Research Fellow, DMPK Project Lead to guide the DMPK strategy for our Biotherapeutics portfolio including protein, antibody, ADC and cell and genetic therapies. The responsibilities will span from early research through clinical development. This leader will play a central role in ensuring that PK, bioanalysis, ADME, and translational PKPD insights are fully integrated into program decision-making and development plans. The ideal candidate will bring deep strategic and technical expertise in DMPK for one or more biotherapeutic modalities described above, have demonstrated leadership in a matrixed environment, and have the ability to influence cross-functional teams and governance bodies at Vertex.

Responsibilities

• Serve as the DMPK Lead and/or supervise other DMPK leads for biotherapeutics programs, develop and execute DMPK scientific strategies from discovery through clinical development.
• Build and maintain strong collaborative partnerships with Biology, Preclinical Safety, Clinical Pharmacology, CMC and other R & D disciplines to align DMPK strategy with overall program goals and advance Vertex programs through discovery and development.
• Represent DMPK function on drug discovery and development teams and with Vertex R & D governance bodies, driving data-informed decisions related to PK, immunogenicity, disposition, metabolism, and biotransformation of biotherapeutics.
• Provide scientific and managerial leadership to the team in prioritizing and executing on key deliverables and project needs.
• Oversee design, execution, and interpretation of PK, ADME, and bioanalytical/immunogenicity assays for biotherapeutics and guide translational PKPD approaches to support dose selection and clinical projections.
• Provide clear communication on DMPK findings, implications, and recommendations to team members and senior leadership.
• 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.
• Help shape long-term DMPK strategy, capabilities, and best practices for biotherapeutics across the organization.
• Participate in review of business development opportunities.

Qualifications

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, Biology, or related field, with 15+ years of industry experience
• Successful track record and experience in a DMPK lead role on multiple R&D 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.
• Experience preparing regulatory submissions and interacting with health authorities.
• Strong management and leadership skills, with emphasis on developing and mentoring junior DMPK project leads.