Senior Medical Lead

Biocon Biologics Limited; Bengaluru; Sur place; INR 3 500 000 - 7 000 000; Plein temps

Résumé du poste

Biocon Biologics Limited is seeking a Medical Lead to drive clinical strategy across the product lifecycle. You will provide medical oversight for clinical trials, ensure regulatory compliance, and lead cross-functional collaboration with internal teams and CROs.

The role requires 10+ years in clinical development, strong regulatory expertise for biologics, and proven leadership. You will interact with global regulatory authorities and contribute to strategic development plans and safety

Qualifications

• 10+ years in clinical development or medical affairs.
• Experience with end-to-end regulatory submissions.
• Experience with novel biologics or complex molecules preferred.
• Strong knowledge of GCP and regulatory guidelines.
• Excellent stakeholder management and communication skills.

Responsabilités

• Lead clinical strategy from development through regulatory submission.
• Provide medical oversight for trials per GCP and SOPs.
• Coordinate regulatory interactions with authorities (USFDA/EMA/CSDSCO).
• Prepare and review regulatory documents and safety materials.
• Mentor medical/scientific staff and collaborate with CROs and teams.
• Oversee safety monitoring, data review, and trial documentation.
• Ensure accurate registry data and CSR inputs.
• Support publications and scientific communications.

Connaissances

Clinical development

Regulatory submissions

GCP compliance

Medical monitoring

Leadership

Formation

Bachelor's or Master's in Life sciences/ MBBS/MD

Description du poste

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 strong expertise in clinical development, medical monitoring, and regulatory interactions, particularly for novel biologics and molecules.

Key Responsibilities:

1. 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 new 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.

2. Clinical Trial Oversight & Execution

• Provide medical oversight for clinical trials in compliance with GCP, SOPs, and regulatory requirements.
• Support study conduct activities including site selection, investigator interactions, and vendor/CRO management.
• Attend and contribute to study initiation meetings, investigator meetings, and governance boards/committees.
• Review study-level data, including GCP issue reports, protocol deviations, and safety signals.
• Conduct medical monitoring, including review of lab alerts, SAEs, and EDC data.
• Ensure accuracy of trial information in registries such as ClinicalTrials.gov and CTRI.
• Support database lock (DBL) activities and provide inputs on Tables, Listings, and Figures (TLFs).

3. Regulatory & Scientific Engagement

• Lead scientific interactions with regulatory authorities for clinical aspects (IND, IMPD, MAA/CTD submissions).
• Prepare and review regulatory documents, including briefing books, protocol synopses, safety documents, and annual updates.
• Support responses to regulatory, marketing, and molecule-related queries.
• Participate in advisory boards, Clinical Advisory Boards (CAB), DSMB meetings, and regulatory discussions.

4. Medical Writing & Documentation

• Prepare and review key clinical documents including protocols, ICFs, SAP, DMP, SMP, DSMB charter, MMP, imaging charter, and CSRs.
• Collaborate with medical writers to review and finalize Clinical Study Reports (CSR), including discussions and conclusions.
• Provide inputs into statistical outputs and interim analysis (DSMB meetings).

5. Safety & Pharmacovigilance

• Monitor subject safety throughout clinical trials and review safety data.
• Collaborate with pharmacovigilance teams for preparation and review of safety documentation.
• Ensure timely identification, escalation, and resolution of safety concerns.

6. Compliance, Audits & Quality

• Ensure adherence to GCP, regulatory requirements, and internal SOPs.
• Support audits and regulatory inspections.
• Contribute to SOP development, review, and continuous process improvements.

7. Stakeholder & Team Management

• Manage interactions with CROs, vendors, investigators, and cross-functional teams.
• Line manage and mentor medical/scientific staff (if applicable).
• Participate in external scientific discussions, partnerships, and consultant engagements.

8. Scientific Communication

• Support dissemination of scientific knowledge through publications, presentations, and training initiatives.

Academic Qualification:

• Bachelors or Master's degree, equivalent or higher qualification within Life sciences/ Pharmacy/ MBBS /MD/ Healthcare Degree in alternative Medicine/ BDS with at least 10 years of experience in clinical development.
• Additional certification in Clinical Research or Regulatory Affairs is an advantage.

Work Experience:

• 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.).
• 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
• High attention to detail and data interpretation skills