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