Vice President , Global Clinical Lead - Solid Tumor
Takeda
2 days ago
Remote friendly (Boston, MA)
United States
$321,000 - $504,460 USD yearly
Clinical Research and Development
Vice President, Global Clinical Lead – Solid Tumor (Cambridge)
OBJECTIVES
- Lead a large solid tumor oncology franchise covering multiple late-stage and early-phase programs.
- Oversee therapy area strategy documentation review/approval process.
- Oversee development and execution of Integrated Disease Area Strategy (IDAS) and Integrated Global Development Plan (IGDP).
- Review synopses, clinical study documents, and critical study results.
- Provide leadership/oversight of OTAU-related programs (and, if applicable, indication-specific clinical leads).
- Provide guidance to TA leaders on regional therapeutic area specificities.
ACCOUNTABILITIES
- Provide strategic clinical input to assigned studies (accountable to Oncology Clinical Science Head).
- Partner cross-functionally to align global clinical R&D strategy across regions (including regulatory, quantitative/clinical pharmacology, precision/translational medicine, portfolio strategy, launch strategy, and extended oncology leadership).
- Participate in Oncology Clinical Sciences Leadership Team strategic planning.
- Lead global development teams (US/EU and Japan/China) for assigned compounds; ensure proactive identification of contingencies, risks, and mitigation strategies.
- Direct development team strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols), recommending scope/complexity and continually evaluating plans against regulatory requirements.
- Make high-impact global decisions based on internal/external data (including go/no-go decisions and modification of development plans or study designs).
- Ensure regional strategy trade-offs are captured in global documentation and stakeholders are briefed.
- Provide strategic input into global development strategies/plans for all compounds in OTAU.
- Support evaluation of external compounds (alliances and in-licensing opportunities).
- Serve as primary interface with Medical Affairs for strategy and support of product commercial efforts.
- Contribute to regional KOL network; recommend GDT leader nominations and reviewers for external compounds.
- Coordinate logistics planning and study implementation with Clinical Operations and Project Management.
- Critical review of synopses, protocols, Investigator Brochures (IBs), and related documents (Clinical Review Board).
- Review and assess overall safety information with Pharmacovigilance and the Medical Monitor of record.
- Oversee clinical science activities with FDA, other regulatory agencies, and key opinion leaders; evaluate interactions within global development context and develop contingency plans.
- Conduct due diligence on alliances/in-licensing opportunities; serve as clinical contact point for alliance projects and maintain partner relationships.
- Assign/manage clinical science staff supporting these activities.
- Lead internal and global cross-functional teams; prioritize therapeutic area projects.
- Hire, manage, mentor, motivate, develop and retain staff; conduct performance reviews and drive goal setting.
QUALIFICATIONS / EXPERIENCE
- MD or combined MD/PhD (or internationally recognized equivalent) with minimum 15 years pharmaceutical research experience; at least 10 years late-phase clinical development in medical oncology.
- Clinical training/experience in Hematology/Oncology and/or Medical Oncology, especially solid tumor malignancies.
- Deep scientific and clinical understanding of cancer biology, particularly immune-based therapies.
- Experience conducting and/or leading multiple clinical trials involving immune-based therapies.
- Proven experience leading and supervising direct reports (physicians, physician scientists, scientists) in a global matrix environment.
- Demonstrated ability to foster high-performance culture and build organizational capabilities.
- Experience leading global (multi-region) clinical development/matrix teams; clinical development experience beyond US/EU.
- Experience preparing/interacting with regulatory agencies (e.g., FDA, EMA).
- Multiple NDA/MAA submission experience.
- Proven ability to lead/manage highly trained medical, scientific, and technical professionals.
REQUIRED SKILLS
- Strong communication, strategic, interpersonal, negotiation, and influencing skills (verbal and written).
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making within multi-disciplinary, multi-regional matrix teams.
- Diplomacy and positive influencing across multinational business cultures.
TRAVEL REQUIREMENTS
- Travel to meetings/client sites, including overnight and some international travel (approximately 25–35%).
OBJECTIVES
- Lead a large solid tumor oncology franchise covering multiple late-stage and early-phase programs.
- Oversee therapy area strategy documentation review/approval process.
- Oversee development and execution of Integrated Disease Area Strategy (IDAS) and Integrated Global Development Plan (IGDP).
- Review synopses, clinical study documents, and critical study results.
- Provide leadership/oversight of OTAU-related programs (and, if applicable, indication-specific clinical leads).
- Provide guidance to TA leaders on regional therapeutic area specificities.
ACCOUNTABILITIES
- Provide strategic clinical input to assigned studies (accountable to Oncology Clinical Science Head).
- Partner cross-functionally to align global clinical R&D strategy across regions (including regulatory, quantitative/clinical pharmacology, precision/translational medicine, portfolio strategy, launch strategy, and extended oncology leadership).
- Participate in Oncology Clinical Sciences Leadership Team strategic planning.
- Lead global development teams (US/EU and Japan/China) for assigned compounds; ensure proactive identification of contingencies, risks, and mitigation strategies.
- Direct development team strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols), recommending scope/complexity and continually evaluating plans against regulatory requirements.
- Make high-impact global decisions based on internal/external data (including go/no-go decisions and modification of development plans or study designs).
- Ensure regional strategy trade-offs are captured in global documentation and stakeholders are briefed.
- Provide strategic input into global development strategies/plans for all compounds in OTAU.
- Support evaluation of external compounds (alliances and in-licensing opportunities).
- Serve as primary interface with Medical Affairs for strategy and support of product commercial efforts.
- Contribute to regional KOL network; recommend GDT leader nominations and reviewers for external compounds.
- Coordinate logistics planning and study implementation with Clinical Operations and Project Management.
- Critical review of synopses, protocols, Investigator Brochures (IBs), and related documents (Clinical Review Board).
- Review and assess overall safety information with Pharmacovigilance and the Medical Monitor of record.
- Oversee clinical science activities with FDA, other regulatory agencies, and key opinion leaders; evaluate interactions within global development context and develop contingency plans.
- Conduct due diligence on alliances/in-licensing opportunities; serve as clinical contact point for alliance projects and maintain partner relationships.
- Assign/manage clinical science staff supporting these activities.
- Lead internal and global cross-functional teams; prioritize therapeutic area projects.
- Hire, manage, mentor, motivate, develop and retain staff; conduct performance reviews and drive goal setting.
QUALIFICATIONS / EXPERIENCE
- MD or combined MD/PhD (or internationally recognized equivalent) with minimum 15 years pharmaceutical research experience; at least 10 years late-phase clinical development in medical oncology.
- Clinical training/experience in Hematology/Oncology and/or Medical Oncology, especially solid tumor malignancies.
- Deep scientific and clinical understanding of cancer biology, particularly immune-based therapies.
- Experience conducting and/or leading multiple clinical trials involving immune-based therapies.
- Proven experience leading and supervising direct reports (physicians, physician scientists, scientists) in a global matrix environment.
- Demonstrated ability to foster high-performance culture and build organizational capabilities.
- Experience leading global (multi-region) clinical development/matrix teams; clinical development experience beyond US/EU.
- Experience preparing/interacting with regulatory agencies (e.g., FDA, EMA).
- Multiple NDA/MAA submission experience.
- Proven ability to lead/manage highly trained medical, scientific, and technical professionals.
REQUIRED SKILLS
- Strong communication, strategic, interpersonal, negotiation, and influencing skills (verbal and written).
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making within multi-disciplinary, multi-regional matrix teams.
- Diplomacy and positive influencing across multinational business cultures.
TRAVEL REQUIREMENTS
- Travel to meetings/client sites, including overnight and some international travel (approximately 25–35%).