Associate Medical Director Hematology, US OBU Medical Affairs

Position Objectives:
- The Medical Affairs (non-M.D.) Associate Director ensures regulatory approval for new products and maintains product licenses and permits. Monitors regulatory developments, ensures compliance, and prepares regulatory documents.

Position Accountabilities:
- Execute the US medical strategy for CML and Ph+ ALL; engage with healthcare professionals, investigators, and external experts.
- Collaborate cross-functionally with Clinical Development, Commercial, Market Access, and Field Medical teams.
- Support evidence generation, medical education, congress activities, publications, and advisory boards.
- Develop and review scientific materials to ensure accurate and compliant communication of clinical data.
- Ensure organizational awareness and compliance with legislation and regulations.
- Monitor and interpret regulatory developments and assess business impact.
- Implement compliance programs and ensure regulatory reporting/documentation for internal and external audiences.
- Gather, prepare, review, and approve regulatory compliance documents.
- Lead functional teams/projects and provide guidance in complex situations.
- Communicate with leadership and provide consultative expertise.

Education & Skills:
- MD, Ph.D, or Pharm D degree.
- Expert in managing/overseeing clinical trials (protocols and timelines).
- Strategic planning/execution of complex clinical research; data analysis and data-driven decision-making.
- Leadership, negotiation, stakeholder collaboration, and mentoring.

Application instructions:
- No Phone Calls or Recruiters Please.

Benefits (if explicitly stated):
- Medical, dental, vision; 401(k) match; disability; life insurance; tuition reimbursement; paid volunteer time off; holidays; well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.

Work arrangement:
- Hybrid per Takeda’s Hybrid and Remote Work policy.