NLead 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.
NKey Accountabilities
n1. Program Governance & Execution
N- Lead integrated programplanning across CMC, clinical, regulatory, and supply chain
N- Drive governance forumsand executive reporting
N2. Budget & Financial Management
N- Own program budget, forecasting, and cost optimization
N- Deliver variance analysis and financial insights
N3. Regulatory Strategy Alignment
N- Align with FDA, EMA, and global biosimilar guidelines
N- Support filing strategyand lifecycle management
N4. R&D; and Clinical Oversight
N- Coordinate development,strategy discussions, clinical studies execution etc.
N- Manage CRO and CMO engagements and timelines, as may be necessary.
N5. Stakeholder Management
N- Lead cross-functional alignment across internal and external partners
N- Manage CMOs/CROs and contractual deliverables
N6. Risk & Decision Management
N- Identify risks and implement mitigation strategies
N- Enable data-driven decision making
NEducation & Experience
N- Master's / PhD in Life Sciences / Biotechnology / Pharmacy
N- PMP preferred
n-13+ years in biopharmaceutical industry
N- Demonstrated experiencein biosimilar development programs
NCompetencies
n- Advanced program and financial management skills