Global Product Development Lead
Telix Pharmaceuticals Limited
4 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Global Product Development Lead
Key Accountabilities
- Development Leadership: Lead the Global Program Leadership Team (GPLT) and drive cross-functional commitments across CMC, Clinical, and Regulatory; set and communicate GPLT objectives; develop and maintain the Global Development Plan (GDP) and Target Product Profile (TPP).
- Strategic Direction: Guide matrixed teams through complex decision-making and risk management.
- Cross-functional Collaboration: Partner across clinical, non-clinical, regulatory affairs, quality, manufacturing/supply chain, commercial, medical affairs, and program management to achieve milestones.
- Program Governance & Change Management: Lead integrated planning; confirm readiness for key milestones/inflection points; assess and elevate scope/timeline/budget impacts for leadership review; document and communicate decisions.
- Risk Ownership & Communication: Identify, assign ownership of, and manage program risks/issues; communicate risks, mitigations, and decisions.
- Budget Planning & Forecasting: Lead program budget planning/forecasting with Finance and functional leads; monitor spend vs. plan; surface variances and re-forecast.
- Regulatory Pathway Design: Partner with Clinical and Regulatory Affairs to craft the development pathway to support approval and product/commercial objectives.
- Regulatory Interactions & Communication Alignment: Lead preparation for health authority interactions (e.g., FDA Type B) with aligned internal messaging and high-quality briefing materials/responses.
- Executive-Ready Program Reporting: Maintain decision-focused reporting (dashboards, milestone tracking, red/amber/green risks) and ensure leadership visibility with recommended actions/owners.
- Development Planning: Create and execute development plans and data packages to support go/no-go decisions and progress toward approval.
- CMC/Supply & Vendor (CDMO) Alignment: Ensure manufacturing readiness, GMP compliance, and supply continuity; proactively identify constraints and mitigation plans.
- Stakeholder Engagement: Engage internal/external subject matter experts to refine development plans and strategies.
- Global Study Execution & Enrollment Enablement: Collaborate with Clinical Operations and regional teams to anticipate recruitment risks, support site activation strategy, and protect enrollment and global data consistency.
- Inclusive Leadership & Communication: Foster an inclusive, respectful culture and use inclusive language.
Education and Experience
- Master’s or PhD in medical, pharma, or biotech (strongly preferred); 12+ years in pharma/biotech required.
- 5+ years leading cross-functional product teams in pharma/biotech.
- Oncology development and/or radiopharmaceutical experience (distinct advantage).
- Experience in clinical Phase 2 and Phase 3 through approval in the assigned therapeutic area.
- Demonstrated strategic thinking, effective communication, and collaboration in a matrix environment.
- Direct people management experience (advantage).
Key Capabilities (Role-Related)
- Creativity and innovation
- Commitment to excellence
- Results-oriented
- Ethical behavior
- Adaptability
- Strong communication skills
- Collaboration
- Resilience
- Continuous learning
Key Accountabilities
- Development Leadership: Lead the Global Program Leadership Team (GPLT) and drive cross-functional commitments across CMC, Clinical, and Regulatory; set and communicate GPLT objectives; develop and maintain the Global Development Plan (GDP) and Target Product Profile (TPP).
- Strategic Direction: Guide matrixed teams through complex decision-making and risk management.
- Cross-functional Collaboration: Partner across clinical, non-clinical, regulatory affairs, quality, manufacturing/supply chain, commercial, medical affairs, and program management to achieve milestones.
- Program Governance & Change Management: Lead integrated planning; confirm readiness for key milestones/inflection points; assess and elevate scope/timeline/budget impacts for leadership review; document and communicate decisions.
- Risk Ownership & Communication: Identify, assign ownership of, and manage program risks/issues; communicate risks, mitigations, and decisions.
- Budget Planning & Forecasting: Lead program budget planning/forecasting with Finance and functional leads; monitor spend vs. plan; surface variances and re-forecast.
- Regulatory Pathway Design: Partner with Clinical and Regulatory Affairs to craft the development pathway to support approval and product/commercial objectives.
- Regulatory Interactions & Communication Alignment: Lead preparation for health authority interactions (e.g., FDA Type B) with aligned internal messaging and high-quality briefing materials/responses.
- Executive-Ready Program Reporting: Maintain decision-focused reporting (dashboards, milestone tracking, red/amber/green risks) and ensure leadership visibility with recommended actions/owners.
- Development Planning: Create and execute development plans and data packages to support go/no-go decisions and progress toward approval.
- CMC/Supply & Vendor (CDMO) Alignment: Ensure manufacturing readiness, GMP compliance, and supply continuity; proactively identify constraints and mitigation plans.
- Stakeholder Engagement: Engage internal/external subject matter experts to refine development plans and strategies.
- Global Study Execution & Enrollment Enablement: Collaborate with Clinical Operations and regional teams to anticipate recruitment risks, support site activation strategy, and protect enrollment and global data consistency.
- Inclusive Leadership & Communication: Foster an inclusive, respectful culture and use inclusive language.
Education and Experience
- Master’s or PhD in medical, pharma, or biotech (strongly preferred); 12+ years in pharma/biotech required.
- 5+ years leading cross-functional product teams in pharma/biotech.
- Oncology development and/or radiopharmaceutical experience (distinct advantage).
- Experience in clinical Phase 2 and Phase 3 through approval in the assigned therapeutic area.
- Demonstrated strategic thinking, effective communication, and collaboration in a matrix environment.
- Direct people management experience (advantage).
Key Capabilities (Role-Related)
- Creativity and innovation
- Commitment to excellence
- Results-oriented
- Ethical behavior
- Adaptability
- Strong communication skills
- Collaboration
- Resilience
- Continuous learning