 Medical Lead Job at Biocon Biologics
Looking for a senior Medical Lead Job in the biotechnology industry? Biocon Careers presents an exciting opportunity for experienced professionals seeking Jobs in Bengaluru to lead global clinical development programs. This role offers exposure to novel biologics, regulatory interactions, medical monitoring, and cross-functional leadership while contributing to affordable innovation and patient-centric healthcare solutions that impact millions worldwide.
About the Company:
Biocon Biologics is a global leader in the biosimilars revolution, dedicated to creating affordable healthcare solutions for patients worldwide. With expertise spanning development, manufacturing, clinical research, regulatory approvals, and commercialization, the company aims to positively impact a billion lives. Through innovation, patient centricity, and scientific excellence, Biocon continues to shape the future of biotechnology and modern medicine on a global scale.
Job Details:
- Position: Senior Medical Lead
- Location: Bengaluru, Karnataka
- Domain: Clinical Development & Medical Affairs
Job Description:
The Medical Lead Job at Biocon involves leading clinical strategy from Target Product Profile (TPP) development through global regulatory submissions and approvals. Professionals joining through Biocon Careers will oversee clinical trials, regulatory engagements, safety monitoring, medical documentation, and cross-functional collaborations while supporting innovative biologics and complex molecules across international development programs.
Key Responsibilities:
Clinical Strategy & Development:
- Lead clinical strategy development from TPP through global dossier submissions.
- Review and contribute to Clinical Development Plans, Investigator’s Brochures, and study protocols.
- Drive development strategies for novel biologics and molecular entities.
- Develop patient-centric approaches for accelerated clinical execution.
- Provide scientific and medical rationale across therapy areas.
Clinical Trial Oversight & Execution:
- Ensure clinical trial compliance with GCP, SOPs, and regulatory standards.
- Support investigator engagement, site selection, and CRO management.
- Participate in study initiation meetings and governance committees.
- Review protocol deviations, safety reports, and GCP findings.
- Conduct medical monitoring activities, including SAE and laboratory reviews.
- Support database lock processes and statistical outputs.
Regulatory & Scientific Engagement:
- Lead interactions with global agencies, including USFDA, EMA, and CDSCO.
- Prepare and review clinical regulatory documentation.
- Support responses to regulatory and commercialization queries.
- Participate in DSMB meetings, advisory boards, and scientific discussions.
Medical Writing & Documentation:
- Prepare and review:
- Study protocols
- Informed Consent Forms (ICFs)
- Statistical Analysis Plans (SAP)
- Data Management Plans (DMP)
- Clinical Study Reports (CSR)
- Safety documentation and medical charters
Safety & Pharmacovigilance:
- Monitor participant safety throughout clinical programs.
- Collaborate with pharmacovigilance teams on safety evaluations.
- Escalate and resolve emerging safety concerns promptly.
Compliance & Quality:
- Ensure compliance with GCP, internal SOPs, and international regulations.
- Participate in audits and regulatory inspections.
- Contribute to continuous process improvements and SOP development.
Stakeholder Management:
- Manage collaborations with CROs, investigators, consultants, and vendors.
- Mentor scientific and medical teams where applicable.
- Facilitate cross-functional alignment and effective project execution.
Scientific Communication:
- Support scientific publications, presentations, and internal training initiatives.
- Promote dissemination of clinical knowledge across therapeutic areas.
Educational Requirements for a Medical Lead Job:
Candidates applying for this Medical Lead Job should possess:
- Minimum Qualifications in: MBBS / MD / BDS
- Additional certifications in Clinical Research and Regulatory Affairs are preferred.
- Strong exposure to novel biologics and complex molecules.
- Global clinical development experience is highly desirable.
Experience Requirements:
- Minimum 10 years of experience in Clinical Development or Medical Affairs.
- Proven expertise in end-to-end clinical trial management.
- Experience with global regulatory submissions and approvals.
- Exposure to international agencies such as:
- USFDA
- EMA
- CDSCO
- PMDA
Skills Required for a Medical Lead Job:
- Strong clinical and scientific expertise.
- In-depth knowledge of GCP and international regulatory guidelines.
- Excellent stakeholder management abilities.
- Leadership and team mentoring capabilities.
- Strategic thinking and problem-solving skills.
- Strong communication and presentation skills.
- Close attention to detail and analytical thinking.
- Ability to interpret complex clinical and safety data.
- Cross-functional collaboration skills.
