Takeda Pharmaceutical (US)
Director, Global Evidence & Outcomes
Takeda Pharmaceutical (US), Boston, Massachusetts, us, 02298
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Job Description Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, this role informs and contributes to product strategies, clinical development plans and leads the development and execution of integrated evidence generation plans and component research studies (real world evidence and clinical outcomes assessment [COA] studies) for Takeda products to meet evidentiary needs from patients, healthcare providers, regulators, payers and other decision makers.
OBJECTIVES
Contribute to product strategy through membership on matrix teams and interactions with cross‑functional partners.
Provide real‑world evidence and patient‑centered value leadership and consultative expertise for Takeda product(s) from early development through launch and commercialization.
Lead the integrated evidence generation sub‑team for products under development and develop the integrated evidence generation plan. This is a cross‑functional team with global, regional and local members from R&D and commercial.
Lead the development, execution, and communication of real‑world evidence and COA strategies to support regulatory submissions, product labelling, access and commercialization.
Communicate findings from these studies to relevant internal and external audiences as effectively as possible.
May manage a small team depending on the size of global programs/disease areas.
ACCOUNTABILITIES
Work with a multidisciplinary, matrixed organization to ensure product priorities and strategies align with evidentiary requirements and support compelling product value propositions.
Collaborate with product teams/sub‑teams to inform program strategy and plans and prepare for internal governance reviews/decisions.
Assess and identify value evidence requirements from internal and external stakeholders from early development through launch and commercialization of Takeda products under responsibility.
Lead the integrated evidence generation sub‑team for products under development, working with global, regional and local cross‑functional colleagues to develop the integrated evidence generation plan. Ensure local evidence needs are met in line with product strategy.
Lead, develop and execute successful GEO strategies and plans to support evidence needs as defined in the integrated evidence generation plan, clinical development plans and regulatory strategies, including real‑world evidence studies, systematic literature reviews, meta‑analyses, indirect treatment comparisons, observational research, synthetic control arms, predictive models/algorithms, and COA development.
Ensure scientifically robust evidence generation activities are integrated into the development program evidence generation plans.
Effectively manage external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs.
Provide input into clinical development plans, regulatory documents, commercial and access/reimbursement activities and documents.
Prepare and/or review clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports reflecting ongoing or completed work.
Communicate study findings to internal and external audiences, including conference presentations, publications, and dossiers/documents to regulators and authorities.
Network with external researchers to stay current on best practices, new methodologies and enhance Takeda’s visibility in real‑world evidence and COAs.
Comply with all quality and disclosure policies and regulations.
Accountable for product annual plan budget and contract/budget management.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required. Doctoral degree (Ph.D., Sc.D. or Dr.P.H.) in health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences plus 8+ years practical experience. Master’s degree plus 10+ years practical experience also acceptable.
Practical experience in epidemiology and outcomes research and/or COAs in any setting is required.
Experience with regulator and/or HTA/payer policy‑makers and drug development, including launch experience desirable.
Demonstrated experience in conducting complex observational and/or COA studies and communicating findings to internal and external audiences.
Familiarity with observational research in a multidisciplinary drug development and commercialization environment.
Understanding of regulatory and HTA/payer challenges and ability to interact with regulators, HTA/payers and other decision makers.
Strong collaboration and communication skills in a multicultural cross‑functional team.
Broad experience in collaborating with research partners and managing multiple complex projects.
Excellent written and verbal presentation skills and record of high‑quality, peer‑reviewed publications preferred.
Networking, communication and influencing skills with ability to lead cross‑functional teams.
Excellent process and project management skills, including managing multiple complex research studies.
TRAVEL REQUIREMENTS Time commitment expected for travel is approximately 25%‑50% domestic and international.
Takeda Compensation and Benefits Summary For Location: Boston, MA
U.S. Base Salary Range: $174,500.00 – $274,230.00
U.S. employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) with match, disability coverage, life insurance, tuition reimbursement, paid volunteer time, holidays, well‑being benefits, 80 hours of sick time and 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Location Boston, MA Employee – Regular – Full time Job Exempt: Yes
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Job Description Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, this role informs and contributes to product strategies, clinical development plans and leads the development and execution of integrated evidence generation plans and component research studies (real world evidence and clinical outcomes assessment [COA] studies) for Takeda products to meet evidentiary needs from patients, healthcare providers, regulators, payers and other decision makers.
OBJECTIVES
Contribute to product strategy through membership on matrix teams and interactions with cross‑functional partners.
Provide real‑world evidence and patient‑centered value leadership and consultative expertise for Takeda product(s) from early development through launch and commercialization.
Lead the integrated evidence generation sub‑team for products under development and develop the integrated evidence generation plan. This is a cross‑functional team with global, regional and local members from R&D and commercial.
Lead the development, execution, and communication of real‑world evidence and COA strategies to support regulatory submissions, product labelling, access and commercialization.
Communicate findings from these studies to relevant internal and external audiences as effectively as possible.
May manage a small team depending on the size of global programs/disease areas.
ACCOUNTABILITIES
Work with a multidisciplinary, matrixed organization to ensure product priorities and strategies align with evidentiary requirements and support compelling product value propositions.
Collaborate with product teams/sub‑teams to inform program strategy and plans and prepare for internal governance reviews/decisions.
Assess and identify value evidence requirements from internal and external stakeholders from early development through launch and commercialization of Takeda products under responsibility.
Lead the integrated evidence generation sub‑team for products under development, working with global, regional and local cross‑functional colleagues to develop the integrated evidence generation plan. Ensure local evidence needs are met in line with product strategy.
Lead, develop and execute successful GEO strategies and plans to support evidence needs as defined in the integrated evidence generation plan, clinical development plans and regulatory strategies, including real‑world evidence studies, systematic literature reviews, meta‑analyses, indirect treatment comparisons, observational research, synthetic control arms, predictive models/algorithms, and COA development.
Ensure scientifically robust evidence generation activities are integrated into the development program evidence generation plans.
Effectively manage external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs.
Provide input into clinical development plans, regulatory documents, commercial and access/reimbursement activities and documents.
Prepare and/or review clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports reflecting ongoing or completed work.
Communicate study findings to internal and external audiences, including conference presentations, publications, and dossiers/documents to regulators and authorities.
Network with external researchers to stay current on best practices, new methodologies and enhance Takeda’s visibility in real‑world evidence and COAs.
Comply with all quality and disclosure policies and regulations.
Accountable for product annual plan budget and contract/budget management.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required. Doctoral degree (Ph.D., Sc.D. or Dr.P.H.) in health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences plus 8+ years practical experience. Master’s degree plus 10+ years practical experience also acceptable.
Practical experience in epidemiology and outcomes research and/or COAs in any setting is required.
Experience with regulator and/or HTA/payer policy‑makers and drug development, including launch experience desirable.
Demonstrated experience in conducting complex observational and/or COA studies and communicating findings to internal and external audiences.
Familiarity with observational research in a multidisciplinary drug development and commercialization environment.
Understanding of regulatory and HTA/payer challenges and ability to interact with regulators, HTA/payers and other decision makers.
Strong collaboration and communication skills in a multicultural cross‑functional team.
Broad experience in collaborating with research partners and managing multiple complex projects.
Excellent written and verbal presentation skills and record of high‑quality, peer‑reviewed publications preferred.
Networking, communication and influencing skills with ability to lead cross‑functional teams.
Excellent process and project management skills, including managing multiple complex research studies.
TRAVEL REQUIREMENTS Time commitment expected for travel is approximately 25%‑50% domestic and international.
Takeda Compensation and Benefits Summary For Location: Boston, MA
U.S. Base Salary Range: $174,500.00 – $274,230.00
U.S. employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) with match, disability coverage, life insurance, tuition reimbursement, paid volunteer time, holidays, well‑being benefits, 80 hours of sick time and 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Location Boston, MA Employee – Regular – Full time Job Exempt: Yes
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