Medical Director, Clinical Science - Solid Tumor

Job Description

Medical Director, Clinical Science, Solid Tumor – Cambridge office.

The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development, considering medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. They lead a multi‑disciplinary, multi‑regional, matrix team through highly complex decisions. They have ultimate responsibility for development decisions that assess and integrate input from various disciplines to create, maintain, and execute a global clinical development plan that results in regulatory approval of the assigned compound in multiple regions.

They apply clinical/medical decision making to clinical development issues and influence senior leadership decision‑making for the projects by setting strategic direction.

• Clinical Development team participation and leadership
  • Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure activities are aligned with the global strategy.
  • Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state‑of‑the‑art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
  • Responsible for high impact global decisions: monitoring and 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.
• Synopsis / Protocol Development, Study Execution, & Study Interpretation
  • Drives clinical science activities relating to the preparation/approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
  • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Trial Medical Monitoring
  • Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non‑medical clinical scientists with respect to assessment of these issues.
  • Makes final decisions regarding study conduct related to scientific integrity.
• External Interactions
  • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programmes or regulatory applications.
• Due Diligence, Business Development and Alliance Projects
  • Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in‑licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating…