Job DescriptionAre 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.
POSITION OBJECTIVES: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
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: - 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.
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Takeda Compensation and Benefits SummaryWe 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.
For Location:Boston, MA
U.S. Base Salary Range:$169,400.00 - $266,200.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptYes