Bharat Biotech - Head - PMO - New Product Development

Position Summary:

The Head of PMO for the New Product Development division of Bharat Biotech drives the strategic execution of our drug candidate pipeline. Reporting directly to the Chief Development Officer (CDO), you will build, mature, and lead a world-class Project Management Office. You will synchronize clinical development, regulatory affairs, GMP manufacturing, and scale-up plans. Your primary goal is to optimize timelines, manage cross-portfolio dependencies, and maintain strict regulatory compliance from preclinical stages through Phase I-III clinical trials.

Key Responsibilities:

- Translate clinical development strategies into integrated, operational portfolio master plans.

- Apply PM best practices to achieve deliverables on time and build a strong PMO team.

- Prepare and share regular project updates.

- Establish a best project governance model incorporating regular meeting schedules at all levels.

Critical Path Management:

- Oversee the master schedule for drug candidates to maximize pipeline velocity.

Stage-Gate Governance:

- Design and enforce rigorous stage-gate review processes for clinical phase transitions.

- Provide data-driven scenarios to the CDO to optimize portfolio funding and pipeline prioritization.

Regulatory Compliance & Risk Governance:

- GxP Standard Operating Procedures (SOPs): Ensure all PMO methodologies comply with FDA, EMA, ICH-GCP, and local health authority requirements.

- Risk Mitigation: Proactively map technical, clinical, and regulatory risks across the portfolio to avoid timeline slippage.

- Audit Readiness: Maintain a continuous state of audit readiness for all portfolio documentation and project archives.

Resource Optimization & External Vendor Management:

- Budget Accountability: Manage complex R&D/clinical budgets, monitoring variances and capital efficiency across all phases.

- Prepare annual budget for the different projects, track them, and present the variances.

- Liaison with external partners and service providers for successful Technology Transfers.