Sr. Director/Director of Clinical Pharmacology
Director, Clinical Pharmacology
Position Summary:
We are seeking an accomplished and strategic Director of Clinical Pharmacology with deep expertise in oncology drug development. This individual will lead the design and execution of clinical pharmacology strategies across early and late-stage oncology programs, ensuring optimal dose selection, exposure-response understanding, and regulatory success. The ideal candidate will bring a strong scientific foundation, leadership experience, and a passion for advancing innovative cancer therapies.
Key Responsibilities:
- Lead clinical pharmacology strategy for oncology programs from first-in-human through registrational studies.
- Design and oversee clinical pharmacology components of clinical trials, including dose escalation, food effect, DDI, and special population studies.
- Interpret PK/PD, exposure-response, and biomarker data to inform dose selection and therapeutic index.
- Collaborate with cross-functional teams including Clinical Development, Regulatory, Translational Medicine, Biostatistics, and DMPK.
- Guide the development and application of population PK, PK/PD, and exposure-response models in collaboration with pharmacometricians.
- Represent Clinical Pharmacology in regulatory interactions and author relevant sections of INDs, and NDAs/BLAs.
- Mentor and manage junior scientists and contribute to departmental strategy and innovation.
- Stay abreast of emerging trends in oncology pharmacology, modeling, and regulatory science.
Qualifications:
- Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related discipline.
- 10+ years of industry experience in clinical pharmacology, with a strong focus on oncology.
- Proven track record of leading clinical pharmacology strategies for oncology assets, including successful regulatory submissions.
- Deep understanding of oncology drug development, including immuno-oncology, targeted therapies, and ADCs.
- Proficiency in interpreting PK/PD and exposure-response data and applying modeling tools (e.g., NONMEM, Monolix, Phoenix).
- Strong leadership, communication, and cross-functional collaboration skills.
Preferred Qualifications:
- Familiarity with QSP, PBPK modeling, and translational biomarker integration.
- Prior experience interacting with global regulatory agencies (FDA, EMA, PMDA).
FAQs
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