Program Manager – Biosimilar Development

Role PurposeLead 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 Accountabilities1. 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 makingEducation & Experience- Master’s / PhD in Life Sciences / Biotechnology / Pharmacy- PMP preferred- 8–15+ years in biopharmaceutical industry- Demonstrated experience in biosimilar development programsCompetencies- 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 solvingKPIs- On-time milestone delivery - Budget adherence (% variance) - Regulatory submission success - Risk mitigation effectiveness - Stakeholder satisfaction