Associate Medical Director Hematology, US OBU Medical Affairs

The Medical Affairs - non-M.D., Associate Director is responsible for ensuring regulatory approval for new products and maintaining product licenses and permits. This role involves monitoring regulatory developments, ensuring compliance, and preparing regulatory documents to support Takeda's mission of delivering transformative therapies to patients.

POSITION ACCOUNTABILITIES:

• Execution of the US medical strategy for CML and Ph+ ALL.
• Scientific engagement with healthcare professionals, investigators, and external experts.
• Cross-functional collaboration with Clinical Development, Commercial, Market Access, and Field Medical teams.
• Support of evidence generation initiatives, medical education programs, congress activities, publications, and advisory boards.
• Development and review of scientific materials to ensure accurate and compliant communication of clinical data.
• Ensure the organization is aware of and compliant 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

• MD, Ph.D, or Pharm D degree
• Expert 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 towards 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

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

$169,400.00 - $266,200.00

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Medical Director Hematology, US OBU Medical Affairs in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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