At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

About the Role:
The Medical Lead will be responsible for driving clinical strategy across the product lifecycle—from Target Product Profile (TPP) development through regulatory submission and approval. This role provides medical oversight for clinical trials, ensures compliance with global regulatory standards, and leads cross-functional collaboration with internal teams, CROs,



and regulatory authorities. The position requires robust expertise in clinical development, medical monitoring, and regulatory interactions, particularly for novel biologics and molecules.

Key Responsibilities:
Clinical Strategy & Development
Lead clinical strategy development from TPP through dossier submission to global regulatory authorities (e.g., USFDA, EMA, CDSCO).
Contribute to and review Clinical Development Plans (CDP), Investigator’s Brochure (IB), and study protocols.
Drive clinical development strategies for novel biologics and recent molecular entities.
Identify and implement approaches for accelerated trial execution with a patient-centric focus.
Provide medical rationale and scientific justification for products and therapy areas.
Clinical Trial Oversight & Execution
Provide medical oversight for clinical trials in compliance with GCP, SOPs, and regulatory requirements.

📌 Senior Medical Lead Bengaluru (India)
🏢 BIOCON BIOLOGICS
📍 India