Takeda · 1 day ago
Vice President , Global Clinical Lead - Solid Tumor
Takeda is a patient-focused, innovation-driven pharmaceutical company seeking a Vice President, Global Clinical Lead - Solid Tumor in their Cambridge office. This role is responsible for leading the Global Clinical Lead for a large solid tumor oncology franchise, overseeing the development and execution of clinical strategies, and ensuring alignment with global research and development initiatives.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs
Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees
Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP)
Responsible for review of synopses, other relevant clinical study documents and critical Study Results
Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads
Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area
Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies
Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions
Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group
Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds
Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols
Responsible for high impact global decisions interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as 'go/no go' decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling
Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need
Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed
Providing strategic input into global development strategies and plans for all compounds in OTAU
Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
Primary interface with Medical Affairs team for strategy and to support of product commercial efforts
Contributing to the creation and maintenance of regional KOL network
Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts
Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation
Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds
Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds
Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds
Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment
Proactive identification of challenges and development of contingency plans as appropriate
Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment
Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities
Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner
Assigns and manages clinical science staff who are involved in many of these activities
Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area
Leads TGRD internal teams and global cross-functional teams
Works with functional leadership to prioritize projects within the therapeutic area
Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities
Conducts performance reviews and drive goal setting and development planning
Qualification
Required
MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology
Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies
Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies
Experience in conducting and/or leading multiple clinical trials involving immune based therapies
Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment
Demonstrated ability to foster a high-performance culture and build organizational capabilities
Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives
Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EU
Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others
Multiple NDA/MAA submission experience
Proven ability to lead and manage highly trained medical, scientific, and technical professionals
Superior communication, strategic, interpersonal and negotiating skills
Enterprise level leadership with the ability to inspire, motivate and drive results
Excellent communication both verbally and in writing and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners
Ability to proactively predict issues and solve problems
Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
Diplomacy and positive influencing abilities across multinational business cultures
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
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