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