Sr Director, Product Development Lead - 591
Telix Pharmaceuticals Limited
August 07, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Sr Director, Product Development Lead
Key Accountabilities
- Lead global late-stage radiopharmaceutical therapeutic oncology development; own global program leadership across CMC, Clinical, Regulatory, quality, and manufacturing/supply chain.
- Lead the Global Program Leadership Team (GPLT); 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.
- Drive integrated cross-functional planning and readiness for key milestones; assess and elevate scope/timeline/budget impacts and ensure decisions are documented.
- Identify, assign ownership of, and actively manage program risks/issues; communicate risks and mitigations to stakeholders.
- Lead program-level budget planning/forecasting with Finance; monitor spend vs. plan and recommend re-forecasting/trade-offs.
- Partner with Clinical and Regulatory Affairs on regulatory pathway design; lead preparation for health authority interactions.
- Maintain executive-ready, decision-focused program reporting (dashboards, milestone tracking, RAG risks) with owners and recommended actions.
- Create and execute product development plans and data packages to support go/no-go decisions and product approval.
- Align CMC/supply and external vendors (CDMO) to ensure manufacturing readiness, GMP compliance, and supply continuity.
- Enable global study execution and enrollment (site activation, recruitment risk mitigation).
- Foster an inclusive, respectful culture and constructive cross-functional collaboration.
Education and Experience
- Master’s or PhD in medical/pharma/biotech strongly preferred; 12+ years pharma/biotech required.
- 5+ years leading cross-functional product teams.
- Oncology development and/or radiopharmaceutical experience preferred.
- Clinical Phase 2/Phase 3 experience through approval required in the assigned therapeutic area.
- Demonstrated strategic thinking, communication, and collaboration in matrixed environments.
- Direct people management experience is an advantage.
Key Accountabilities
- Lead global late-stage radiopharmaceutical therapeutic oncology development; own global program leadership across CMC, Clinical, Regulatory, quality, and manufacturing/supply chain.
- Lead the Global Program Leadership Team (GPLT); 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.
- Drive integrated cross-functional planning and readiness for key milestones; assess and elevate scope/timeline/budget impacts and ensure decisions are documented.
- Identify, assign ownership of, and actively manage program risks/issues; communicate risks and mitigations to stakeholders.
- Lead program-level budget planning/forecasting with Finance; monitor spend vs. plan and recommend re-forecasting/trade-offs.
- Partner with Clinical and Regulatory Affairs on regulatory pathway design; lead preparation for health authority interactions.
- Maintain executive-ready, decision-focused program reporting (dashboards, milestone tracking, RAG risks) with owners and recommended actions.
- Create and execute product development plans and data packages to support go/no-go decisions and product approval.
- Align CMC/supply and external vendors (CDMO) to ensure manufacturing readiness, GMP compliance, and supply continuity.
- Enable global study execution and enrollment (site activation, recruitment risk mitigation).
- Foster an inclusive, respectful culture and constructive cross-functional collaboration.
Education and Experience
- Master’s or PhD in medical/pharma/biotech strongly preferred; 12+ years pharma/biotech required.
- 5+ years leading cross-functional product teams.
- Oncology development and/or radiopharmaceutical experience preferred.
- Clinical Phase 2/Phase 3 experience through approval required in the assigned therapeutic area.
- Demonstrated strategic thinking, communication, and collaboration in matrixed environments.
- Direct people management experience is an advantage.