Program Manager – Biosimilar Development

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

• 8–15+ 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

KPIs

• On-time milestone delivery

• Budget adherence (% variance)

• Regulatory submission success

• Risk mitigation effectiveness

• Stakeholder satisfaction