Vertex
Biotechnology
ExecutiveDirector,BiotherapeuticsDMPK
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“Executive Director, Biotherapeutics DMPK at Vertex. Skills: Biotherapeutics DMPK-BA, People management, Scientific leadership. Develop vision, strategy, and capabilities for DMPK-BA teams. Develop and execute DMPK-BA scientific strategies”
Industry & Context.
What They're Looking For.
Must Have
PhD in Pharmacokinetics, Biochemistry, Biology, or related field, 15+ years of industry experience at the management level, Managing DMPK-BA teams across more than one therapeutic area, Extensive experience working with one or more biotherapeutic modalities, Experience preparing regulatory submissions, Experience interacting with health authorities
Nice to Have
Developing and mentoring emerging talent
What You'll Do.
and capabilities for DMPK-BA teams
Develop and execute DMPK-BA scientific strategies
Design preclinical PK assays
Execute preclinical PK assays
Interpret preclinical PK assays
Interpret ADME assays
Design bioanalytical assays
Execute bioanalytical assays
Interpret bioanalytical assays
Design immunogenicity assays
Execute immunogenicity assays
Interpret immunogenicity assays
Design translational PKPD approaches
Execute translational PKPD approaches
Interpret translational PKPD approaches
Support dose selection
Support clinical projections
Communicate DMPK-BA findings
Communicate DMPK-BA implications
Communicate DMPK-BA recommendations
Advance Vertex programs
Build collaborative partnerships
Maintain collaborative partnerships
Align DMPK-BA strategy
Implement innovative technologies
Implement innovative approaches
Provide scientific leadership
Provide managerial leadership
Prioritize key deliverables
Execute key deliverables
Prioritize project needs
Execute project needs
Ensure scientific excellence
Ensure regulatory compliance
Support drug development
Develop internal sourcing strategies
Develop external sourcing strategies
Contribute to Global DMPK-BA resource allocation
Contribute to Global DMPK-BA staffing needs
Contribute to Global DMPK-BA expenses
Contribute to Global DMPK-BA capital budget
Contribute to Global DMPK-BA implementation plans
Participate in review of business development opportunities
How You'll Work.
Team & Collaboration
Cross-functional program decision-making; Cross-functional teams; Governance bodies; Biology; Preclinical Safety; Clinical Pharmacology; CMC; R&D disciplines
Communication Scope
Clear communication; Senior leadership communication; Governance bodies communication
Full 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. 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
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