BioSpace
Associate Director Global Evidence and Outcomes
BioSpace, Boston, Massachusetts, us, 02298
Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Associate Director, Global Evidence and Outcomes where you will lead the design, conduct, analyses, interpretation and communication of real-world evidence studies including complex epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization across the product lifecycle in alignment with product evidence generation plans. You will inform and collaborate in the design and conduct of observational studies to support clinical development of Takeda products, including development of synthetic controls.
How You Will Contribute
Collaborates with GEO colleagues and key internal stakeholders to ensure priorities and strategies are aligned.
Contributes to the development and lead the execution of plans addressing unmet evidentiary and patient-centered needs and product value to regulators, HTA/payers, health care providers and patients.
Works with a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies and/or the COA endpoint strategy/plan for one or more therapies in an assigned therapeutic area.
Effectively manages external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs as well as the needs of patients, health care providers and payers.
Provides input into clinical development, regulatory, reimbursement documents.
Performs/manages relevant research activities which may include: Design, conduct, analyses, interpretation, and communication of real-world evidence studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, observational research using existing data and/or collecting new data.
Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports.
Familiarity with software for management and analysis of data.
Follows best practices for data collection, conduct and reporting of real-world evidence and COA studies.
Compliance with all policies and regulations for quality and disclosure.
Accountable for project(s) contract/budget management.
Reviews and develops scientific reports reflecting ongoing or completed work.
Effectively communicates scientific findings internally and externally in conference presentations, publication and other communication mechanisms.
Networks with external researchers in the field in order to remain on top of best practices, new methodologies and enhance Takeda’s visibility in the area of real-world evidence and COAs.
Minimum Requirements/Qualifications
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 health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 5+ years practical experience. Masters degree in a related discipline (as noted above), plus 7+ years practical experience.
Practical experience in performing epidemiology and outcomes research and/or COAs, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
Strong technical expertise required in design and conduct of observational studies, predictive modeling or COAs as well as the scientific communication of study findings.
Demonstrated experience in conducting or interpreting statistical analysis is useful.
Experience in conducting research in different geographic regions and interacting with regulators and/or HTA/payer, policy makers.
Ability to work collaboratively and effectively in a multicultural and cross functional team environment is expected.
Ability to work in a global environment, independently as well as in a team and to manage multiple projects to tight deadlines with strong orientation to detail.
Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
Record of high-quality, peer-reviewed publications is preferred.
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About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Associate Director, Global Evidence and Outcomes where you will lead the design, conduct, analyses, interpretation and communication of real-world evidence studies including complex epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization across the product lifecycle in alignment with product evidence generation plans. You will inform and collaborate in the design and conduct of observational studies to support clinical development of Takeda products, including development of synthetic controls.
How You Will Contribute
Collaborates with GEO colleagues and key internal stakeholders to ensure priorities and strategies are aligned.
Contributes to the development and lead the execution of plans addressing unmet evidentiary and patient-centered needs and product value to regulators, HTA/payers, health care providers and patients.
Works with a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies and/or the COA endpoint strategy/plan for one or more therapies in an assigned therapeutic area.
Effectively manages external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs as well as the needs of patients, health care providers and payers.
Provides input into clinical development, regulatory, reimbursement documents.
Performs/manages relevant research activities which may include: Design, conduct, analyses, interpretation, and communication of real-world evidence studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, observational research using existing data and/or collecting new data.
Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports.
Familiarity with software for management and analysis of data.
Follows best practices for data collection, conduct and reporting of real-world evidence and COA studies.
Compliance with all policies and regulations for quality and disclosure.
Accountable for project(s) contract/budget management.
Reviews and develops scientific reports reflecting ongoing or completed work.
Effectively communicates scientific findings internally and externally in conference presentations, publication and other communication mechanisms.
Networks with external researchers in the field in order to remain on top of best practices, new methodologies and enhance Takeda’s visibility in the area of real-world evidence and COAs.
Minimum Requirements/Qualifications
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 health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 5+ years practical experience. Masters degree in a related discipline (as noted above), plus 7+ years practical experience.
Practical experience in performing epidemiology and outcomes research and/or COAs, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
Strong technical expertise required in design and conduct of observational studies, predictive modeling or COAs as well as the scientific communication of study findings.
Demonstrated experience in conducting or interpreting statistical analysis is useful.
Experience in conducting research in different geographic regions and interacting with regulators and/or HTA/payer, policy makers.
Ability to work collaboratively and effectively in a multicultural and cross functional team environment is expected.
Ability to work in a global environment, independently as well as in a team and to manage multiple projects to tight deadlines with strong orientation to detail.
Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
Record of high-quality, peer-reviewed publications is preferred.
#J-18808-Ljbffr