Senior Medical Director, Oncology, Marketed Products Medical and Development

Takeda•Boston, MA

4d•$257,600 - $404,800

About The Position

The Senior Medical Director (SMD) in Global Clinical Science and Medical Affairs, Marketed Products Medical and Development (MPMD), Global Medical, leads the global clinical development scientific strategy for marketed products, considering medical, scientific, regulatory, and lifecycle issues. The role usually supports multiple products, including at least one complex product, and provides clinical scientific leadership for assigned global program teams and/or product sub-teams. The SMD partners with Global Program Leads, Global Project Managers, and R&D subject-matter experts to set development strategy and priorities. The role provides medical sponsor oversight for clinical development programs and helps ensure Takeda meets its obligations as Marketing Authorization Holder. The SMD maintains expert knowledge of assigned products’ scientific, clinical, and regulatory aspects, providing guidance, mentoring, and leadership while helping teams anticipate compliance risks and prepare contingency plans. The position leads cross-functional clinical development activities, including study design, execution, oversight, interpretation, and regulatory support. It also applies appropriate AI tools and digital platforms to improve clinical science activities and decision-making. The SMD collaborates across internal functions, commercial organizations, local operating companies, strategic vendor partners, and external scientific and regulatory stakeholders. The role additionally participates in clinical due diligence and development planning for potential alliances and in-licensing opportunities.

Requirements

MD or internationally recognized equivalent.
At least 8 years of clinical research experience within the pharmaceutical industry, a CRO, a health-related consulting company, or biomedical/clinical experience in academia, or a combination of these settings.
Training and experience in oncology, including hematologic and/or solid tumor malignancies.

Responsibilities

Lead and drive global clinical development scientific strategy for assigned marketed products, incorporating medical, scientific, regulatory, and lifecycle considerations.
Make product lifecycle decisions using Takeda’s PTRB framework, balancing patient needs, scientific integrity, stakeholder trust, corporate reputation, and business value.
Provide strategic leadership to Global Program Teams, Product Sub-Teams, and/or Clinical Sub-Teams and drive cross-functional execution of scientific objectives.
Apply AI tools, internal digital platforms, and emerging technologies to improve Clinical Science activities, clinical-trial data evaluation, reporting, and decision-making; collaborate with DD&T-related functions on innovative approaches.
Partner with Global Program Leads and Global Project Management to deliver medical and clinical support and coordinate R&D functional support for assigned products.
Establish partnerships with R&D functional leads, including regulatory affairs, patient safety and pharmacovigilance, global development operations, statistics, and quality, to align strategy and achieve program goals.
Partner with the Center for Post Approval Safety Studies on PASS responsibilities, strategic alignment, and compliance.
Collaborate with commercial organizations, local operating companies, and cross-divisional stakeholders, including Quality, Global Manufacturing and Supply, Medical Affairs, Evidence Generation, GEO/HEOR, Global Commercial, and regional business units.
Lead clinical scientific activities for the preparation and approval of study synopses and protocols and the conduct of clinical studies supporting lifecycle management, post-marketing requirements, and registration needs.
Provide Takeda oversight of strategic partner medical doctors and clinical staff involved in clinical development activities.
Ensure the design, execution, and interpretation of clinical studies, including appropriate integration of longitudinal and cross-sectional safety and efficacy data, data quality, and adherence to applicable regulations and ICH requirements.
Oversee strategic vendor partners and the quality of their clinical deliverables; ensure appropriate ongoing medical monitoring and medical data review to protect study participants.
Assess study and compound safety information with Patient Safety and Pharmacovigilance, evaluate protocol conduct and subject-safety issues, and make final decisions on study conduct related to scientific integrity.
Present study conclusions to senior leadership and assess how study results affect product strategy; interpret data from scientific, regulatory, and patient medical-significance perspectives.
Participate in and support regulatory submissions and interactions; represent Takeda as Responsible Medical Doctor and clinical expert to global regulatory agencies as needed, and support LOC medical staff during agency interactions.
Develop clinical and scientific content for regulatory documents and submissions, meeting presentations, and responses to regulatory communications.
Participate in cross-functional initiatives and committees on behalf of Global Clinical Science and Medical Affairs in MPMD.
Provide scientific education and mentoring to internal and external audiences, including academic partners and the scientific community.
Oversee compliance with internal SOPs and external legal requirements, including personnel training and contractual arrangements with external service providers and partner companies.
Build and maintain relationships with medical and clinical experts to support state-of-the-art therapeutic and clinical scientific expertise for assigned products.
Represent Takeda’s clinical development perspective at regulatory meetings and external bodies as needed.
Participate in, conduct, and oversee clinical due diligence and development plans for potential alliances and in-licensing opportunities.
Assess scientific and development feasibility, portfolio fit, clinical trials, regulatory interactions, and future development plans; engage with potential partner or acquisition-company leadership and internal assessment teams.