About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive workplace where collaboration and individual growth go hand in hand.

As an Operational PK/PD Expert, you will provide operational support to the Global Early Phases Clinical Expert and contribute to the development, registration, and commercialization of products across the portfolio.

Responsibilities include:
- Lead and coordinate PK/PD activities across early-phase clinical programs.
- Oversee outsourced PK/PD studies and manage relationships with external CROs and vendors.
- Ensure the quality, integrity, and regulatory compliance of PK/PD data generated throughout studies.
- Review and contribute to clinical, regulatory, and scientific documentation (e.g., submissions, investigator brochures, briefing books).
- Support the design, execution, and interpretation of pharmacokinetic and pharmacodynamic studies.
- Perform and/or review PK analyses and modeling activities using industry-standard tools.




- Provide scientific expertise on bioavailability, bioequivalence, drug-drug interaction, and bioanalytical topics.
- Ensure studies are conducted in compliance with ICH-GCP, SOPs, and applicable regulatory requirements.
- Collaborate with cross-functional teams to support evidence generation and decision-making.
- Contribute to the delivery of high-quality data suitable for regulatory submissions, publications, and commercial use
Requirements

Profile

Experience: Proven experience in Pharmacokinetics within the pharmaceutical, consumer healthcare, FMCG, or related industries, Proven experience in the design, execution, and/or management of PK clinical studies, Experience overseeing outsourced studies and managing external CROs or vendors is highly desirable, Exposure to OTC products and clinical evidence generation is a strong advantage.

Skills: Strong expertise in Pharmacokinetics/Pharmacodynamics and P

📌 PK/PD Expert (Bengaluru)
🏢 Excelya
📍 Bengaluru