What are the responsibilities and job description for the (Sr.) Director, DMPK, Orexin Program position at centessapharmaceuticalsinc?
Company
Centessa Pharmaceuticals plc (Nasdaq: CNTA) is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
DMPK/Senior Director, Orexin Programs
Position Summary:
The Director/Senior Director, DMPK will be responsible for leading the Drug Metabolism and Pharmacokinetics (DMPK) activities across a portfolio of Orexin agonist programs, guiding the strategy and execution of DMPK studies from early discovery through clinical development for small molecule drugs. This role requires a deep understanding of pharmacokinetics, pharmacodynamics, drug metabolism, and bioanalytical methodologies as applied to drugs acting in the central nervous system (CNS).
Key Responsibilities:
- Provide strategic direction and oversight to ensure high-quality and timely delivery of DMPK data.
- Hands-on role in 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.
- Collaborate within project teams and across other functional groups including pharmacology, toxicology, CMC, medicinal chemistry, and clinical colleagues.
- Build and maintain strong relationships working directly with CROs, consultants and other external partners to enhance DMPK resources and capabilities.
- 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 supporting clinical development.
Education and Qualifications:
- 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 the CNS area.
- 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 for CNS drug targets.
- Experience and working knowledge of US and EU regulatory submissions.
- Strong leadership skills with experience managing and mentoring scientific teams.
Work Location
This is a remote role based in the US, with infrequent (<10%) travel to our headquarters in Boston, MA.
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.