Associate Medical Director, Clinical Science, NS TAU

Role Summary

Associate Medical Director, Clinical Science, NS TAU leads and drives strategy for clinical studies within global development for assigned neuroscience pipeline compounds, balancing medical, scientific, regulatory and commercial considerations. They lead or join multi-disciplinary, multi-regional teams to design, execute and interpret studies that support regulatory approvals across regions. The role involves influencing senior leadership, guiding study development plans, and ensuring data-driven decisions to advance Takeda’s portfolio. Location: Cambridge, MA. Travel may be required.

Responsibilities

• Lead and drive strategy for clinical studies within the global development plan for assigned pipeline compound(s), integrating medical, scientific, regulatory and commercial considerations.
• Lead or join multi-disciplinary, multi-regional teams through highly complex decisions; develop, maintain and execute studies to support regulatory approval in multiple regions; apply clinical/medical decision making to development issues.
• Influence Neuroscience Therapeutic Area Unit senior leadership by contributing to strategic direction.
• Represent Clinical Science on Study Execution and Clinical Teams, and may co-lead these teams; support Global Project Team to align activities with global strategy.
• Act as Global Clinical Lead for early clinical stage or preclinical programs with interactions with translational and biomarker colleagues and preclinical teams.
• Contribute to Asset Strategy, Clinical Development Plan, Protocols and other documents; recommend scope, complexity and size, and influence the budget of all aspects of a study or program; maintain a state-of-the-art development plan that is competitive and compliant; develop contingency plans.
• Monitor and interpret data from ongoing studies; assess medical and scientific implications; make recommendations such as go/no-go decisions or modifications that may impact timelines or product labeling.
• Oversee synopsis/protocol development, study execution and interpretation; advise other clinical scientists; ensure successful design and interpretation of clinical studies.
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or subject safety; review safety information with Pharmacovigilance; supervise non-medical clinical scientists as needed; make final decisions on study conduct to maintain scientific integrity.
• Direct interactions with key opinion leaders; lead meetings and negotiations; develop materials outlining company positions on research programs or regulatory applications; incorporate feedback into study design and program development.
• Evaluate potential business development opportunities; conduct due diligence; contribute to clinical development plans for alliances or in-licensing opportunities; interface with potential partners to achieve strategic goals while maintaining good working relationships.
• Mentor and develop staff; lead internal task forces and cross-functional teams as appropriate.

Qualifications

• MD, MD/PhD, or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical academia (or a combination).
• Previous experience successfully leading matrix teams (preferred).
• Previous experience in designing and executing first-in-human and early proof-of-concept trials (preferred).

Skills

• Superior communication, strategic, interpersonal and negotiating skills.
• 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.

Education

• MD, MD/PhD, or internationally recognized equivalent.

Additional Requirements

• Travel: Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Approximately 10–20% travel.
• Hybrid work policy: This position is currently classified as “hybrid.”