Associate Medical Director Hematology, US OBU Medical Affairs

About the Role

The Associate Medical Director in Hematology, US OBU Medical Affairs is a key role responsible for ensuring regulatory approval for new products and maintaining product licenses and permits. This position involves monitoring regulatory developments, ensuring compliance, and preparing regulatory documents to support Takeda's mission of delivering transformative therapies to patients with hematologic conditions.

Responsibilities

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

Qualifications

• MD, Ph.D., or Pharm D degree.

Skills

• Expertise in managing and overseeing clinical trials, ensuring adherence to protocols and timelines.
• Skilled in strategic planning and execution of complex clinical research projects.
• Proficient in data analysis and interpretation, capable of making data-driven decisions.
• Strong leadership skills, able to guide and motivate a team toward achieving research objectives.
• Experienced in negotiation, able to effectively manage study costs and design.
• Effective collaborator, adept at working with different stakeholders including external partners.
• Experienced mentor, capable of fostering talent and encouraging professional growth within the team.

Schedule

This position is classified as "hybrid" in accordance with Takeda’s Hybrid and Remote Work policy.

Pay

For the location Boston, MA, the U.S. base salary range is $169,400.00 - $266,200.00. The actual base salary offered may depend on factors such as qualifications, relevant experience, skills, education, certifications, and location.

U.S.-based employees may be eligible for short-term and/or long-term incentives.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per calendar year.

Location: Cambridge, MA (Boston area). This is a full-time, exempt position.