Director, Global Evidence & Outcomes
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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to the best of my knowledge.Job DescriptionGlobal 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.Key position objectives are to:
- 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
- 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 size of global
- Work with a multidisciplinary, matrixed organization, to ensure
product priorities and strategies are aligned to meet evidentiary
requirements/needs and support compelling product value
- Collaborate and partner with product teams/sub teams to inform
program strategy and plans and to prepare for internal governance
- 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
- 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
- Develop, assess and interpret COAs to derive clinical benefit
during the clinical development and commercialization.
- Execution of COA endpoints strategy/plan for a specific
product(s) such as conduct qualitative and quantitative research to
inform development on conceptual disease-models, design and execute
studies in whole or in part to generate evidence on the validity of
COA endpoints and produce COA evidence dossiers for regulatory
submissions. Interact as necessary with Agencies.
- Ensure scientifically robust evidence generation activities are
integrated into the development program evidence generation
- 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
- 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
- Compliance with all policies and regulations for quality and
- 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.
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.
- regulator and/or HTA/payer policy-makers.
- Drug development experience is required and launch experience
- 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
- 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.
- Record of high-quality, peer-reviewed publications is
- Networking, communication and influencing skills. Ability to
lead cross-functional teams.
- Excellent process and project management skills including the
ability to manage multiple complex research studies.
- Ability to influence without authority, particularly
individuals at senior levelsBase Salary Range: $137,200 to
$196,000, based on candidate professional experience level.
Employees may also be eligible for Short Term and Long-Term
Incentive benefits as well. Employees are eligible to participate
in Medical, Dental, Vision, Life Insurance, 401(k), Charitable
Contribution Match, Holidays, Personal Days & Vacation, Tuition
Reimbursement Program and Paid Volunteer Time Off. EEO
StatementTakeda 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.LocationsUSA - MA - Cambridge - Binney StWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Rochester , Director, Global Evidence & Outcomes, Executive , Walworth, New York
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