Program Manager - Biosimilar Development

<p><strong>Role Purpose </strong> </p><p><br /></p><p>Lead end-to-end biosimilar development programs across R&amp;D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets. </p><p><br /></p><p><strong>Key Accountabilities </strong> </p><p><strong>1 </strong>. <strong>Program Governance &amp; Execution </strong> </p><p>- Lead integrated program planning across CMC, clinical, regulatory, and supply chain </p><p>- Drive governance forums and executive reporting </p><p><strong>2. Budget &amp; Financial Management </strong> </p><p>- Own program budget, forecasting, and cost optimization </p><p>- Deliver variance analysis and financial insights </p><p><strong>3. Regulatory Strategy Alignment </strong> </p><p>- Align with FDA, EMA, and global biosimilar guidelines </p><p>- Support filing strategy and lifecycle management </p><p><strong>4. R&amp;D and Clinical Oversight </strong> </p><p>- Coordinate development, strategy discussions, clinical studies execution etc. </p><p>- Manage CRO and CMO engagements and timelines, as may be necessary. </p><p><strong>5. Stakeholder Management </strong> </p><p>- Lead cross-functional alignment across internal and external partners </p><p>- Manage CMOs/CROs and contractual deliverables </p><p><strong>6. Risk &amp; Decision Management </strong> </p><p>- Identify risks and implement mitigation strategies </p><p>- Enable data-driven decision making </p><p><br /></p><p><strong>Education &amp; Experience </strong> </p><p>- Master’s / PhD in Life Sciences / Biotechnology / Pharmacy </p><p>- PMP preferred </p><p>- 13+ years in biopharmaceutical industry </p><p>- Demonstrated experience in biosimilar development programs </p><p><br /></p><p><strong>Competencies </strong> </p><p>- Advanced program and financial management skills </p><p>- Strong understanding of biosimilar regulatory pathways (US/EU) </p><p>- Cross-functional leadership and stakeholder management </p><p>- Excellent communication and influencing skills </p><p>- Strategic thinking and problem solving </p>