Centessa Pharmaceuticals · 19 hours ago

(Sr.) Director, DMPK, Orexin Program

Boston, MA

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

10+ years exp

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Responsibilities

Provide strategic direction and oversight to ensure high-quality and timely delivery of DMPK data.

Develop and implement DMPK strategies that align with Centessa’s drug discovery and development objectives.

Collaborate within project teams and across other functional groups including pharmacology, toxicology, CMC, medicinal chemistry, and clinical

Oversee the design, execution and interpretation of in vitro, in vivo, and in silico DMPK studies including robust assessment of ADME properties, transporters, prediction of human PK and dose projections, PK/PD relationships and drug-drug interaction potential.

Provide expert interpretation of DMPK data and present findings to project teams, senior management and external stakeholders.

Responsible for reviewing BA and TK reports from non-GLP and GLP tox studies, and for conducting Pk/TK analysis and preparing reports as needed.

Prepare and review DMPK sections for regulatory submissions (IND, IB, etc) and other relevant documents for clinical development.

Build and maintain strong relationships with CROs, consultants and other external partners to enhance DMPK resources and capabilities.

Qualification

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PharmacokineticsDrug MetabolismBioanalytical MethodologiesSmall Molecule DMPK ExperienceDMPK Modeling ToolsPK/PD ModelingWinNonlinRegulatory SubmissionsMentoring Teams

Required

PhD in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, or a related field with a focus on drug metabolism/pharmacokinetics.

10+ years of small molecule DMPK experience within the pharmaceutical/biotechnology industry with a proven track record of leading DMPK efforts.

In-depth knowledge of DMPK principles, including ADME, PK/PD modeling, dose projections and bioanalytical methods with hands on calculation of PK parameters using WinNonlin or similar software.

Adept in the use of DMPK modeling and simulation tools.

Experience and working knowledge of US and EU regulatory submissions.

Strong leadership skills with experience managing and mentoring scientific teams.