Medical Director, Clinical Science - Solid Tumor

Role Summary

Medical Director, Clinical Science - Solid Tumor located in Cambridge. Role focused on leading global clinical development strategy for assigned Takeda pipeline compounds, integrating medical, scientific, regulatory and commercial considerations to drive regulatory approvals across regions.

Responsibilities

• Clinical Development team participation and leadership:
  • Lead Global (US/EU/Japan) Development Team for a given product; represent Clinical Science on the Global Development Team to align with global strategy.
  • Establish and drive Development Team strategy and deliverables including Development Strategy, Clinical Development Plan, and Clinical Protocols; assess scope, complexity, budget; maintain a state-of-the-art development plan with contingency plans.
  • Make high-impact global decisions by monitoring data and recommending actions such as go/no-go or modifications to plans or study designs.
• Synopsis / Protocol Development, Study Execution, & Study Interpretation:
  • Drive clinical science activities for synopses, protocols, and conduct of clinical studies; advise clinical scientists; present study conclusions to Management and determine impact on compound strategy.
  • Interpret data with medical significance for patients.
• Trial Medical Monitoring:
  • Oversee medical monitoring, assess protocol conduct and subject safety; evaluate safety information with Pharmacovigilance; supervise non-medical clinical scientists as needed; make final decisions on study conduct related to scientific integrity.
• External Interactions:
  • Direct regulatory interactions and relationships with key opinion leaders; lead strategy for regulatory applications, prepare documents and responses, and incorporate advice into study designs.
• Due Diligence, Business Development and Alliance Projects:
  • Identify and evaluate BD opportunities; conduct due diligence; develop clinical development plans for alliances/in-licensing; interface with potential partners to achieve strategic goals.
• Leadership, Task Force Participation, Upper Management Accountability:
  • Collaborate with research divisions and TPNA/TPEU; may lead cross-functional teams; hire, manage, mentor, and develop staff; conduct performance reviews and development planning.

Qualifications

• MD, MD/PhD, or internationally recognized equivalent with 5 years of clinical research experience in pharma, CRO, or academia (or combination).
• Hematology/Oncology and/or Medical Oncology experience in solid tumors preferred.
• Experience in immune-based therapies and/or antibody-drug conjugates preferred.
• Late-phase clinical development and NDA/MAA submission experience preferred.
• Previous experience leading a clinical development/matrix team across multiple regions.
• Management experience.

Skills

• Excellent communication and influencing skills; ability to engage and influence stakeholders at all levels.
• Ability to drive decision-making in multi-disciplinary, multi-regional 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.

Travel Requirements

• Ability to travel to meetings or client sites, including overnight trips; some international travel may be required.
• Approximately 15 - 25% travel.