Key Accountabilities
- Lead the Global Program Leadership Team (GPLT) and be accountable for cross-functional commitments across CMC, Clinical, and Regulatory; set GPLT objectives; develop and maintain the Global Development Plan (GDP) and Target Product Profile (TPP).
- Provide strategic direction and guide matrixed teams through complex decision-making and risk management.
- Collaborate across clinical, non-clinical, regulatory affairs, quality, manufacturing/supply chain, commercial, medical affairs, and program management to achieve milestones.
- Drive integrated planning and governance/change management; ensure scope/timeline/budget impacts are assessed and elevated for leadership review; document and communicate decisions.
- Identify, assign ownership of, and manage program risks/issues; communicate risks, mitigations, and decisions.
- Lead program-level budget planning/forecasting; monitor spend vs. plan and drive reforecasting/trade-offs.
- Partner with Clinical and Regulatory Affairs to design the regulatory development pathway.
- Lead preparation for key health authority interactions (e.g., FDA Type B) and align internal communication, messaging, and briefing materials.
- Maintain executive-ready program reporting (dashboards, milestone tracking, RAG risks) with recommended actions and owners.
- Create and execute development plans and data packages to support go/no-go decisions toward approval.
- Align with Technical Operations, Quality, and CDMOs/vendors to ensure manufacturing readiness, GMP compliance, and supply continuity.
- Engage subject matter experts to refine development plans and strategies.
- Collaborate on global study execution and enrollment enablement, including recruitment risk mitigation.
- Foster inclusive, respectful leadership and use inclusive language.
Education and Experience (Required/Preferred)
- Masterβs or PhD in medical/pharma/biotech (preferred); 12+ years in pharma/biotech (required).
- 5+ years leading cross-functional product teams (required).
- Oncology development and/or radiopharmaceutical experience (advantage).
- Clinical Phase 2/Phase 3 experience through approval in the assigned therapeutic area (required).
- Direct people management experience (advantage).