Band
Level 5

Job Description Summary
As Associate Director, Translational Medicine Expert (TME), Clinical Pharmacology (CP TME), you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with cross functional Clinical Pharmacology Trial Teams, project level TMEs, and CRO collaborators to ensure the highest standards of medical supervision, participant safety, and scientific quality.
TM Clinical Pharmacology is a cross‑functional expert group responsible for the design, execution, and reporting of First‑in‑Human (FiH) and Clinical Pharmacology studies across all therapeutic areas. Operating through a strategic outsourcing model, we partner with qualified CROs while maintaining robust sponsor oversight of all strategic elements, including study design, regulatory engagement, and timelines.

Location: Hyderabad

Job Description
Role Overview
As a Associate Director, Translational Medicine Expert (TME), Clinical Pharmacology (CP TME),



you will serve as the primary medical and scientific leader for FiH and Clinical Pharmacology studies. You will partner closely with cross‑functional Clinical Pharmacology Trial Teams, project‑level TMEs, and CRO collaborators to ensure the highest standards of medical supervision, participant safety, and scientific quality.
This role directly shapes early and full development programs across the BR portfolio and plays a critical part in delivering high‑quality data that informs program decisions and regulatory submissions.

Your Responsibilities
1. Clinical Pharmacology Portfolio Leadership
· Lead and manage multiple FiH and Clinical Pharmacology studies simultaneously with medical, scientific, and operational excellence
· Provide expert Clinical Pharmacology input into Study Concept Sheets, protocols, Informed Consent Forms, Statistical Analysis Plans, and TLF shells
· Oversee medical and safety aspects of studies, including Site Initiation Visits, ongoing safety revi

📌 Associate Director, Translational Medicine Expert, TM Clinical Pharmacology (Hyderabad)
🏢 Novartis
📍 Hyderabad