Chief Scientific Manager
Location: Bangalore, India
Company: Biocon Pharma Limited
Department: Medical Affairs & NRA
Job ID: 19426
Employment Type: Full-Time
Estimated Salary: ₹40–55 LPA (based on role seniority, experience range, and industry benchmarks)
Role Summary:
The Chief Scientific Manager at Biocon Pharma will lead and oversee the Clinical Research Unit (CRU), ensuring regulatory-compliant execution of Bioequivalence (BE) studies and contributing to strategic clinical development activities. The role requires coordination across internal and external stakeholders for clinical program planning, execution, regulatory submissions, and dossier support for global markets.
Key Responsibilities:
1. CRU Head Responsibilities:
Monitor and manage BE studies end-to-end
Oversee Investigational Medicinal Product (IMP) logistics and compliance
Qualify and evaluate CROs for clinical study execution
Draft and finalize protocol synopsis, study protocols, and reports
Prepare Controlled Correspondence, Scientific Advice, SEC Meeting briefs, and Executive Summaries for regulatory submissions
Respond to regulatory queries and prepare clinical/non-clinical overviews
Lead IVIVC modeling and BE prediction strategy
Collaborate with Formulation & Development (FnD) to enhance study success
Estimate budgets and assess new products for global submissions
Maintain project trackers and ensure budget adherence for CRO-managed studies
Coordinate contracts (CDA, MSA, project-level) with legal, finance, and CROs
Serve as Departmental Training Coordinator
2. CRU Clinical Operations:
Execute and monitor BE studies
Ensure proper management and documentation of IMP
Evaluate and qualify CRO capabilities
3. CRU Program Management:
Conduct product evaluations and budget planning
Support dossier submissions for international markets
Monitor timelines, coordinate internal teams, CROs, and vendors
Oversee study execution within approved budgets
4. CRU Medical Writing and Review:
Prepare and review clinical documentation including:
Protocol Synopsis
Study Protocol and Reports
Scientific Advice Documents
Regulatory Response Documents
Clinical Overviews (including device-related ones)
5. Regulatory & Strategic Clinical Support:
Conduct preclinical PK and toxicity studies
Provide scientific input on clinical development strategies for generics/complex generics
Use simulation software to support formulation development and IVIVC
Educational & Experience Requirements:
Education: Ph.D. in a relevant life sciences or pharmaceutical discipline
Experience: 10–20 years of experience in clinical research and scientific management, including regulatory submissions, BE study operations, and CRO oversight
Why Join Biocon Pharma:
Opportunity to lead clinical development for a leading pharmaceutical firm
Involvement in global regulatory strategy and clinical execution
Cross-functional leadership and high-level scientific advisory role
Inclusive and innovation-driven culture
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