Lead end-to-end biosimilar development programs across R&D;, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.
Key Accountabilities
Program Governance & Execution
Lead integrated program planning across CMC, clinical, regulatory, and supply chain
Drive governance forums and executive reporting
Budget & Financial Management
Own program budget, forecasting, and cost optimization
Deliver variance analysis and financial insights
Regulatory Strategy Alignment
Align with FDA, EMA, and global biosimilar guidelines
Support filing strategy and lifecycle management
R&D; and Clinical Oversight
Coordinate development, strategy discussions, clinical studies execution etc.
Manage CRO and CMO engagements and timelines, as may be necessary.
Stakeholder Management
Lead cross-functional alignment across internal and external partners
Manage CMOs/CROs and contractual deliverables
Risk & Decision Management
Identify risks and implement mitigation strategies
Enable data-driven decision making
Education & Experience
Master’s / PhD in Life Sciences / Biotechnology / Pharmacy
PMP preferred
13+ years in biopharmaceutical industry
Demonstrated experience in biosimilar development programs
Competencies
Advanced program and financial management skills
Robust understanding of biosimilar regulatory pathways (US/EU)
Cross-functional leadership and stakeholder management
Excellent communication and influencing skills
Strategic thinking and problem solving
📌 Program Manager Biosimilar Development Bengaluru
🏢 BIOCON BIOLOGICS
📍 Bengaluru
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