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 response.

Qualifications

- PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, or related field

Required Skills

- Minimum of 10 years of industry experience in clinical pharmacology, with demonstrated expertise in supporting clinical development of NMEs for dermatology and/or oncology.
- Strong understanding of clinical PK analysis, PK/PD, PK modeling and simulations including pop PK, PBPK, QSP etc, biostatistics, and translational science with NCEs, NBEs and ADCs.
- Basic understanding of bioanalytical techniques, including method development and validation for pharmacokinetic assessments.
- Familiarity with radiolabel studies and their application in absorption, distribution, metabolism, and excretion (ADME) profiling.
- Proven track record in early-phase clinical development and global regulatory submissions.
- Excellent knowledge of global regulatory requirements for Clinical Pharmacology data.

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