Director, Global Evidence & Outcomes jobs in United States
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Takeda · 1 day ago

Director, Global Evidence & Outcomes

Takeda is a global biopharmaceutical company focused on developing and delivering innovative therapies. The Director of Global Evidence & Outcomes will lead the development and execution of integrated evidence generation plans to support product strategies and clinical development, ensuring alignment with regulatory and commercial needs.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Contribute to product strategy thorough membership on matrix teams and through interactions with cross-functional partners
Provide real-world evidence and patient-centered value leadership and consultative expertise for Takeda product(s) under responsibility 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
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 size of global programs/disease areas
Work with a multidisciplinary, matrixed organization, to ensure product priorities and strategies are aligned to meet evidentiary requirements/needs and support compelling product value propositions
Collaborate and partner with product teams/sub teams to inform program strategy and plans and to prepare for internal governance reviews/decisions
Assess and identify value evidence requirements/needs from internal and external stakeholders (patients, healthcare providers, regulators, HTAs/payers, and other decision makers) from early development through launch and commercialization of Takeda products under responsibility
Lead the integrated evidence generation sub team for products under development, and working with global, regional and local cross-functional colleagues lead the development of 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/or regulatory strategies including, but not limited to 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, development of synthetic control arms that include pre-existing data to support clinical development programs, and predictive models/algorithms
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 as well as the needs of patients, health care providers and payers
Provide input into clinical development plans, regulatory documents with accuracy and scientific integrity as well as into 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
Effectively communicates study findings to internal and external audiences, and as appropriate in conference presentations, publications, and dossiers/documents to regulators and/or other authorities
Network 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
Compliance with all policies and regulations for quality and disclosure
Accountable for product annual plan budget and contract/budget management

Qualification

Outcomes researchEpidemiologyReal-world evidenceDrug developmentClinical development plansStatistical analysisProject managementNetworking skillsCommunication skillsTeam leadership

Required

Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required. This may be 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
Masters degree in a related discipline (as noted above), plus 10+ years practical experience
Practical experience (years noted above 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
Drug development experience is required and launch experience is desirable
Demonstrated experience in the conduct of complex observational and/or COA studies, and the interpretation and communication of study findings to internal and external audiences
Employs advanced technical expertise to solve research questions/problems
Familiarity with the role and importance of observational 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 as well as interacting with regulators, HTA/payers and/or other decision makers is highly 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 required
Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required
Excellent process and project management skills including the ability to manage multiple complex research studies
Ability to influence without authority, particularly individuals at senior levels

Preferred

Oncology experience preferred
Record of high-quality, peer-reviewed publications is preferred
Networking, communication and influencing skills. Ability to lead cross-functional teams

Benefits

Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation

Company

Takeda

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Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.

H1B Sponsorship

Takeda has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)

Funding

Current Stage
Public Company
Total Funding
$2.46B
2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M

Leadership Team

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Christophe Weber
President and CEO
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Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
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Company data provided by crunchbase