Role Summary
Vice President, Global Clinical Lead - Solid Tumor is responsible for leading a large solid tumor oncology franchise across multiple late-stage and early-phase programs. The role oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and the Integrated Global Development Plan (IGDP), and provides strategic clinical input and leadership to regional and global teams. The position involves collaboration with Medical Affairs, Regulatory, and external partners to drive global clinical research alignment and complex development decisions.
Responsibilities
- Clinical Development team participation and leadership
- Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies
- Partner with key functions and leaders across Oncology to align global clinical research and development strategy for internal and external initiatives
- Be part of the Oncology Clinical Sciences Leadership Team providing input in strategic planning for the Oncology Clinical Sciences group
- Lead the Global Development Team managing US/EU and Japan/China development efforts for assigned compounds; oversee study physicians and clinical scientists to address risks and obstacles
- Direct Development Team strategy and deliverables, including Development Strategy, Clinical Development Plan, and Clinical Protocols; assess budget implications and ensure plans remain state-of-the-art and compliant
- Make high-impact global decisions interpreting data from ongoing studies and propose modifications to development plans or study designs as needed
- Ensure regional strategies are integrated into global strategy documentation and stakeholders are briefed
- Provide strategic input into global development strategies for all OTAU compounds
- Support evaluation of external compounds (alliances, in-licensing opportunities)
- Interface with Medical Affairs to support product commercial efforts and maintain regional KOL networks
- Recommend GDT leader nominations and reviewers of external compounds as part of BD efforts
- Liaise with Clinical Operations and Project Management for study planning and implementation
- Synopsis/Protocol Development, Study Execution, and Study Interpretation within Clinical Review Board membership
- Trial Medical Monitoring: review safety information with Pharmacovigilance and the Medical Monitor of record
- External Interactions: lead clinical science activities with regulatory agencies and key opinion leaders; evaluate external interactions within global development context
- Due Diligence, Business Development and Alliance Projects: evaluate BD opportunities, conduct due diligence on clinical development plans, and manage alliance projects with external partners
- Leadership: manage and mentor staff, lead internal and cross-functional teams, hire and develop talent, conduct performance reviews
Qualifications
- MD or MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including at least 10 years in late-phase clinical development focused on medical oncology
- Clinical training/experience in Hematology/Oncology and/or Medical Oncology, especially solid tumor malignancies
- Strong depth of scientific and clinical understanding in cancer biology and immune-based therapies
- Experience leading multiple clinical trials involving immune-based therapies
- Proven track record of leading and supervising direct reports within a global matrix environment
- Demonstrated ability to foster high-performance culture and build organizational capabilities
- Commitment to diversity, equity, and inclusion; experience creating inclusive, collaborative teams
- Experience leading clinical development teams with global study responsibility beyond US/EU
- Experience interacting with multiple regulatory agencies (FDA, EMA, etc.) and NDA/MAA submissions
- Strong leadership, communication, negotiating, and strategic skills; ability to influence stakeholders at all levels
- Proactive problem-solving and ability to drive decisions within multi-regional teams
- Diplomacy and positive influencing abilities across multinational cultures
Skills
- Strategic Clinical Development
- Global cross-functional leadership
- Regulatory agency engagement
- Due diligence and alliance management
- Clinical protocol and study design development
- Risk management and contingency planning
- KOL network development
- Conflict resolution and high-stakes decision making
Education
- MD or MD/PhD (or internationally recognized equivalent) with extensive pharmaceutical research experience in oncology
Additional Requirements
- Travel: willingness to travel internationally; approximately 25-35% travel
- Hybrid work arrangement as per company policy