Clinical Pharmacology Lead

Sun Pharma · Bhubaneswar, Odisha · Posted 22 days ago

About this role

We are seeking a strategic and scientifically driven Clinical Pharmacology Lead to support the development of innovative therapies in Dermatology (topical products), Immunology and Oncology (biologics). This role will be instrumental in designing and executing clinical pharmacology and model informed drug development (MIDD) strategies across early-phase development programs, with a strong emphasis on global clinical development and regulatory engagement. Responsibilities • Lead clinical pharmacology strategy for dermatology and oncology programs from pre-IND through early clinical development and beyond. • Collaborate with cross-functional teams including discovery, translational sciences, clinical operations, regulatory affairs, and biostatistics. • Design and oversee Phase I and early Phase II studies including FIH, SAD/MAD, bioavailability, and PK/PD studies, maximum use studies for topical formulations tailored to topical compounds and biologics and ADCs. • Integrate clinical pharmacology data and utilize appropriate modeling and simulation approaches (e.g., PK/PD, PBPK, PopPK, ER response etc) to support dose selection, formulation optimization, and study design. • Analyze and interpret pharmacokinetic and pharmacodynamic data to inform clinical decisions and development milestones. • Author and review clinical pharmacology sections of regulatory documents (INDs, IBs, CTDs, briefing books) and scientific publications. • Represent clinical pharmacology in global regulator