Associate Director / Director, Clinical Pharmacology

JOB SUMMARY

The Associate Director/Director will be responsible for designing and executing clinical pharmacology strategy for oncology small-molecule programs, including PK/PD study design, dose selection and optimization, and the use of modeling and simulation approaches (e.g., PBPK, population PK) to inform program decisions. This role partners closely with Clinical Development, DMPK, Biostatistics, and Regulatory Affairs to author and review protocols and clinical pharmacology sections of regulatory submissions (IND/IMPD, briefing documents, and CTD modules) and to prepare responses to health authority queries. The role also contributes to drug-drug interaction, organ impairment, and cardiac safety (QT) assessment strategies for small-molecule oncology assets, ensuring alignment with current FDA/EMA/ICH guidance (including ICH M12), and may mentor junior scientists within the function.

KEY RESPONSIBILITIES

• Represent Clinical Pharmacology line function and work on multi-disciplinary oncology small-molecule program teams (clinical, DMPK, regulatory, biometrics, CMC, etc.), supporting programs from late-stage discovery and IND-enabling activities through Phase 1 dose escalation/expansion and beyond.

• Independently analyze, interpret and report clinical P