Medical Director, Clinical Science - Solid Tumor

Role Summary

Medical Director, Clinical Science, Solid Tumor. Location: Cambridge, MA (hybrid). The role leads and drives strategy for the global (US/EU/Japan) clinical development of assigned Takeda pipeline compounds, coordinating a multi-disciplinary, multi-regional matrix team to create, maintain, and execute a global development plan that supports regulatory approval across regions. It applies clinical/medical decision making to development issues and interacts with senior leadership to set strategic direction and ensure future product success.

Responsibilities

• Clinical Development team participation and leadership:
  • Leads Global (US/EU/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 influences 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. Responsibilities include leadership roles in meetings with regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications from regulatory organizations or opinion leaders. Lead roles will also be taken on incorporating advice / recommendations into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.
• 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 strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations, and representing clinical science on internal assessment teams.
  • 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.
• Leadership, Task Force Participation, Upper Management Accountability:
  • Interacts directly with the research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions. Lead TGRD internal teams and may lead global cross-functional teams, as appropriate.
  • Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drives goal setting and development planning.

Qualifications

• MD, combined MD/PhD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Preferred: Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies.
• Preferred: Experience in conducting and/or leading clinical trials involving immune-based therapies and/or antibody-drug conjugates.
• Preferred: Late phase clinical development and NDA/MAA/Submission experience.
• Preferred: Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• Preferred: Management experience.

Skills

• Excellent communication 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.

Knowledge

• Therapeutic area knowledge relevant to mechanism of action.
• Regional/global Regulatory requirements.
• GCP/ICH.
• Emerging research in designated therapeutic area.

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 15–25% travel.
• Hybrid work arrangement.