Senior Medical Director, Oncology, Marketed Products Medical and Development

Takeda•Boston, MA

About The Position

The Senior Medical Director (SMD) in Global Clinical Science and Medical Affairs, Marketed Products Medical and Development (MPMD), leads the scientific strategy for global clinical development of marketed products. The role considers medical, scientific, regulatory, and product life-cycle issues and is usually responsible for multiple products, including at least one complex product. The SMD partners with MPMD Global Program Leads, Global Project Managers, and R&D subject-matter experts to establish clinical development strategy and priorities, and provides clinical scientific leadership for assigned global program and/or sub-team teams. The role also provides medical sponsor oversight for MPMD clinical development programs, supporting Takeda’s obligations as the marketing authorization holder. The SMD serves as the clinical scientific expert for assigned products, maintaining current knowledge of their scientific, clinical, and regulatory aspects. The SMD provides guidance, mentoring, and leadership; anticipates compliance risks and develops contingency plans; and supports teams in responding to regulatory, scientific, and commercial challenges. The role leads cross-functional clinical development activities, studies, data interpretation, medical monitoring oversight, regulatory interactions and submissions, external medical relationships, and clinical due diligence for potential alliances or licensing opportunities. It also promotes the appropriate use of AI, digital platforms, and other technologies to improve clinical science activities and decision-making.

Requirements

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

Responsibilities

Lead global clinical development scientific strategy for assigned marketed products, considering medical, scientific, regulatory, and life-cycle issues.
Make product life-cycle decisions using Takeda’s PTRB framework, balancing patient needs, scientific integrity, stakeholder trust, corporate reputation, and business value.
Provide strategic and clinical scientific leadership to Global Program Teams, Product Sub-Teams, and Clinical Sub-Teams, and support their program goals and organizational KPIs.
Lead the use of appropriate AI tools, internal digital platforms, and emerging technologies to improve Clinical Science activities and clinical trial data evaluation and reporting.
Partner with Global Program Leads, Global Project Management, R&D functional leads, commercial organizations, local operating companies, and cross-divisional stakeholders to coordinate support and execute clinical development activities.
Drive preparation and approval of study synopses and protocols and conduct clinical studies supporting life-cycle management, post-marketing requirements, and regional or local registrations.
Provide Takeda oversight of strategic partners and vendors, including clinical deliverables, medical monitoring, and medical data review; address protocol conduct and individual subject safety issues.
Oversee the design, execution, and interpretation of clinical studies, including the integrity and quality of data analysis and integration of safety and efficacy data.
Assess study and compound safety information in conjunction with Patient Safety and Pharmacovigilance and make final decisions on study conduct related to scientific integrity.
Present study conclusions to senior leadership and determine their impact on product strategy.
Support regulatory submissions and interactions; represent Takeda as the responsible medical doctor and clinical expert when needed.
Develop clinical and scientific content for regulatory applications, submissions, meeting materials, and formal responses to regulatory agencies.
Participate in cross-functional initiatives and committees and provide scientific education and mentoring to internal and external audiences.
Oversee compliance with internal standard operating procedures 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 and represent Takeda’s clinical development perspective at regulatory meetings and external bodies.
Participate in and oversee clinical due diligence and development planning for potential alliances and in-licensing opportunities, assessing scientific and development feasibility, portfolio fit, trials, regulatory interactions, and future plans.