We are seeking a strategic and scientifically driven Clinical Pharmacology Lead to support the development of cutting-edge 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 regulatory interactions (FDA, EMA, PMDA) and contribute to submission strategies.
- Oversight of bioanalysis of large and small molecules including method development and validation for pharmacokinetic assessments and oversight of sample management in clinical studies.
- Stay current with advances in topical drug delivery systems in dermatology and biologic therapies in oncology.
- Contribute to biomarker strategy and translational approaches to enhance understanding of drug mechanism and patient respon

📌 Clinical Pharmacology Lead (Vadodara)
🏢 Sun Pharma Advanced Research Company
📍 Vadodara