Director, Global Evidence & Outcomes – Rare Disease
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
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Director, Global Evidence & Outcomes – Rare DiseaseApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Global Evidence & Outcomes – Rare Disease 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.
This position functions within Takeda’s Global Evidence & Outcomes (GEO) team, which contributes to the successful development and commercialization of new, innovative therapies. As Takeda focuses and organizes itself into teams focused on rare diseases, neurosciences, gastroenterology and oncology, the purpose of this position is to provide global outcomes research support for one of these therapeutic areas.
As a member of the GEO team assigned to one or more global program teams, this person will inform and contribute to program strategies with comprehensive evidence generation plans and component research studies that identify clinical, economic, and patient-centered unmet needs, and the comparative clinical, and patient-centered value that Takeda’s medicines provide in addressing those needs. Position objectives are:
- To provide outcomes research leadership and consultative expertise for Takeda products from early development through launch and commercialization.
- To collaborate and align internally with other Takeda R&D and Business Unit teams within a multi-disciplinary framework to meet product needs.
- To contribute to the development and execution of plans to elucidate unmet clinical, economic and patient-centered needs and product value to regulators, HTA/payers, health care providers and patients.
- To design, execute and communicate results of appropriate tactical activities supporting those plans, including observational and epidemiologic research as well as experimental trials.
- To communicate findings from these studies to relevant internal and external audiences as effectively as possible.
- Work within a multidisciplinary, matrixed organization to lead, develop and execute successful GEO strategies and plans for one or more therapies in an assigned therapeutic area.
- Using observational research expertise, design, implement and communicate results of outcomes research studies, that help achieve product-specific objectives.
- Represent the GEO function and provide strategic input on corporate cross-functional teams related to product development and commercialization to enable and support informed decision making.
- Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned.
- Perform, as appropriate, relevant research activities which may include, but not be limited to:
- Design, execution, and analysis in whole or in part of longitudinal prospective observational or randomized clinical trials evaluating clinical, patient-centered, and/or economic endpoints;
- Longitudinal retrospective studies of existing databases to assess patient characteristics, treatment patterns, and associated clinical, economic and/or patient-reported outcomes;
- Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence;
- Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities;
- Clinical-disease models and assessments exploring burden of illness and/or comparative effectiveness.
- Targeted or comprehensive systematic literature reviews;
- Development and validation of PRO and HRQoL instruments.
- Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs), and reports.
- Prepare, review, and publish scientific reports reflecting ongoing or completed work.
- Align with internal stakeholders to meet the outcomes and epidemiology research needs of local operating companies.
- Communicate with relevant internal and external audiences, which may include regulators, health care providers/practitioners, HTA authorities/payers, patients and others.
- Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, dossiers and other means.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Experience in one or more disciplines within outcomes research in Takeda-relevant therapeutic areas is preferred. Demonstrated experience in observational studies is highly desirable.
- Combination of academic training and practical experience in outcomes research is required. This may consist of:
- 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
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a master’s degree in a related discipline (as noted above), plus 10 years practical experience
- Master’s degree in a related discipline (as noted above), plus 10 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.
- Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences.
- Familiarity with the role and importance of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is expected.
- 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.
- Demonstrated expertise in at least one area of outcomes research (such as, but not limited to, retrospective or prospective observational studies, patient-reported outcomes/health-related quality of life assessment, clinical-economic modeling and analysis, literature synthesis/meta-analysis) is highly desirable.
- Knowledge of health economics is desirable.
- Demonstrated experience in conducting or interpreting statistical analysis is useful.
- Excellent qualitative and quantitative skills, including study design analysis and interpretation of data from observational research.
- Experience in conducting outcomes research in different geographic regions is desirable.
- Ability to work collaboratively and effectively in a multicultural and cross functional team environment is expected.
- Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is very desirable.
- Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Experience interacting with regulator and/or HTA/payer policy-makers is highly desirable.
- Record of high-quality, peer-reviewed outcomes research publications is preferred.
- Takeda is a global company with corporate headquarters in Japan, and with global research and development activities run from Cambridge, Massachusetts, USA.
- Travel to meetings (sometimes requiring overnight stays) involving Takeda colleagues, research partners, and/or external stakeholders is a requirement of the position.
- Some international travel may be required.
- Time commitment expected for travel is approximately 10 - 25 %.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
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Job ID R0022053