Associate Director, Clinical Pharmacology/ Senior Clinical Pharmacologist (Oncology)
Core
Conceive, execute, and manage multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements for oncology projects.
Role type
Senior IC clinical pharmacologist (oncology) with strategic leadership
Builds
Clinical pharmacology and PK/PD strategies, study designs, regulatory documents, and scientific publications for oncology assets
Domain
Biopharmaceuticals / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, PK/PD study design, pharmacometrics, drug metabolism/transporters, regulatory document authoring, cross-functional team leadership, scientific publication, KOL interaction, business development due diligence
Preferred skills
PBPK modeling, systems pharmacology, exposure-response analysis, CMC collaboration
Technologies
PK/PD modeling tools, PBPK platforms, CTD formatting
Responsibilities
Design Phase 1-4 studies and clinical pharmacology strategy; lead teams in data analysis and interpretation of MoA and disease specifics; author regulatory documents including protocols, study reports, population PK reports, and CTDs; lead clinical pharmacology meetings and represent the function at strategy teams; drive unified clinical pharmacology positions across clinical, CMC, and regulatory teams; conduct due diligence for business development; represent Clinical Pharmacology at regulatory meetings
Seniority
Senior, hands-on IC with strategic oversight