Medical Lead Job at Biocon Biologics
Are you ready to take the lead in shaping the future of biosimilars? A remarkable opportunity has emerged for experienced professionals in the pharmaceutical sector. Biocon Biologics is seeking a Senior Medical Lead to drive clinical strategy and ensure compliance with global regulatory standards in Bengaluru, Karnataka, India. This Medical Lead Job offers a chance to work with a leading company in the biosimilars revolution. Dive into a career that focuses on patient-centric innovation and impacts a billion lives.
About Biocon Biologics:
Biocon Biologics is a leading company in the biosimilars revolution, dedicated to creating a model for the future of healthcare. With a focus on patient-centric innovation, the organisation aims to impact a billion lives by providing high-quality, affordable biosimilars. The company operates globally, leveraging its extensive expertise in development, manufacturing, clinical development, regulatory approvals, and commercialisation.
Job Details:
- Position: Senior Medical Lead
- Location: Bengaluru, Karnataka, India
Job Description:
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 strong expertise in clinical development, medical monitoring, and regulatory interactions, particularly for novel biologics and molecules.
Key Responsibilities:
- 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 new molecular entities.
- Identify and implement approaches for accelerated trial execution with a patient-centric focus in the Medical Lead Job in Bengaluru.
- Provide medical rationale and scientific justification for products and therapy areas.
- Provide medical oversight for clinical trials in compliance with GCP, SOPs, and regulatory requirements at Biocon Biologics.
- Support study conduct activities including site selection, investigator interactions, and vendor/CRO management.
- Lead scientific interactions with regulatory authorities for clinical aspects (IND, IMPD, MAA/CTD submissions).
Eligibility Criteria for the Medical Lead Job:
- Bachelors or Master’s degree, equivalent or higher qualification within MBBS /MD/ Healthcare Degree in alternative Medicine/ BDS with at least 10 years of experience in clinical development.
- 10+ years of experience in Clinical Development / Medical Affairs within the pharmaceutical or biotechnology industry.
- Proven experience in end-to-end clinical trial management and regulatory submissions.
- Experience in novel biologics, complex molecules, or global clinical programs preferred.
- Strong exposure to regulatory interactions (USFDA, EMA, CDSCO, PMDA, etc.).
Required Skills for the Medical Lead Job:
- Strong clinical and scientific acumen.
- In-depth knowledge of GCP, regulatory guidelines, and clinical trial processes.
- Excellent stakeholder management and communication skills.
- Strategic thinking and problem-solving ability.
- Leadership and team management capability.
- A close attention to detail and data interpretation skills.
