Program Manager - Biosimilar Development

Job description

**Role Purpose** 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** **1** . **Program Governance & Execution** - Lead integrated program planning across CMC, clinical, regulatory, and supply chain - Drive governance forums and executive reporting **2. Budget & Financial Management** - Own program budget, forecasting, and cost optimization - Deliver variance analysis and financial insights **3. Regulatory Strategy Alignment** - Align with FDA, EMA, and global biosimilar guidelines - Support filing strategy and lifecycle management **4. R&D and Clinical Oversight** - Coordinate development, strategy discussions, clinical studies execution etc. - Manage CRO and CMO engagements and timelines, as may be necessary. **5. Stakeholder Management** - Lead cross-functional alignment across internal and external partners - Manage CMOs/CROs and contractual deliverables **6. 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 - Strong understanding of biosimilar regulatory pathways (US/EU) - Cross-functional leadership and stakeholder management - Excellent communication and influencing skills - Strategic thinking and problem solving