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Director, Clinical Outcomes Assessment, Global Evidence & Outcomes

Takeda Pharmaceutical

Boston, MA 02108

RemoteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required.
Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 8+ years practical experience
Practical experience (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
A minimum of 5 years of Patient Reported Outcomes experience is required.
Demonstrated experience in interpreting statistical analysis is required.
Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
Working knowledge of Patient Focused Drug Development (PFDD) Guidance documents and other relevant guidance documents and best practices is required.
Ability to understand regulatory and HTA/payer challenges for Takeda products; and to critically review data and assimilate strategies that take such environments into consideration is required.
Familiarity with the role and importance of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is required.
Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences.
Expertise and experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is expected.
Must be capable of leading teams, influencing teams, and driving decisions; must also be able to work effectively as a member of different teams.
Experience with the drug development process in the pharmaceutical industry is strongly preferred. Regulatory understanding and experience in negotiating PRO label claims is strongly preferred. Experience with ePRO is strongly preferred.
Oncology experience is highly desirable
Ability to work collaboratively and effectively in a multicultural and cross functional team environment.
Experience managing budgets is expected.
Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment is highly desirable.
Experience in conducting outcomes research in different geographic regions and interacting with regulator and/or HTA/payer policy-makers is highly desirable.