Senior Medical Director, Clinical Science -Solid Tumor

Role Summary

Senior Medical Director leads and drives strategy for the global clinical development of multiple Takeda pipeline compounds, coordinating medical, scientific, regulatory, and commercial considerations across regions. Responsible for developing and executing a global clinical development plan and for high-level global decisions impacting timelines, labeling, and product viability.

Responsibilities

• Clinical Development team participation and leadership:
  • Lead the Global Development Team (US, EU, Japan) for assigned compounds, overseeing development strategy and proactive risk mitigation.
  • Direct Development Team strategy and deliverables, including Development Strategy, Clinical Development Plan, and Clinical Protocols; assess scope and budget implications; ensure plans remain state-of-the-art and compliant with regulatory requirements.
  • Make high-impact global decisions by interpreting data from ongoing studies and advising on go/no-go decisions or modifications to development plans and study designs.
• Synopsis / Protocol Development, Study Execution, & Study Interpretation:
  • Drive activities related to preparation and approval of synopses and protocols; oversee conduct of clinical studies; provide contingency planning to ensure objectives are achieved; interpret data within medical context for patient significance.
• Trial Medical Monitoring:
  • Oversee medical monitoring, assess protocol conduct and subject safety, and review overall safety information in conjunction with Pharmacovigilance.
• External Interactions:
  • Direct interactions with regulatory authorities and key opinion leaders; provide leadership and guidance to clinical scientists involved in these activities.
• Due Diligence, Business Development and Alliance Projects:
  • Identify and evaluate business development opportunities; conduct due diligence; develop and negotiate clinical development plans for alliances or in-licensing; interface with potential partner management during negotiations.
• Leadership, Task Force Participation, Upper Management Accountability:
  • Collaborate with research and cross-functional teams; lead internal and external task forces; hire, coach, and develop staff; conduct performance reviews and development planning.

Qualifications

• MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO, or academic settings (including 3–4 years of late-stage clinical development).
• Training and experience in Hematology/Oncology and/or Medical Oncology, especially solid tumor malignancies, is highly preferred.
• Experience in conducting and/or leading clinical trials involving immune-based therapies and/or antibody-drug conjugates is highly preferred.
• Previous experience leading a clinical development team/matrix team with responsibility for studies in multiple regions; development experience beyond US/EU is a plus.
• NDA/MAA/Submission experience is preferred.
• Excellent communication and influencing skills; ability to engage, inspire, and influence stakeholders at all levels, including executives and external partners.
• Experience in leading and managing highly trained medical, scientific, and technical professionals is preferred.

Skills

• Superior communication, strategic, interpersonal, and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities across multinational business cultures

Knowledge

• Therapeutic area knowledge relevant to mechanisms of action of compounds in remit
• 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%).