Director Global Evidence & Outcomes
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: September 15, 2023
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAt 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.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.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
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 size
of global programs/disease areas.ACCOUNTABILITIES: 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.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 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 COAsCompliance with all policies
and regulations for quality and disclosureAccountable 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 experienceMasters 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 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
requiredAbility to communicate scientific evidence, with strong
written and verbal presentation skills, is required.Record of
high-quality, peer-reviewed publications is preferred.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 levelsLICENSES/CERTIFICATIONS:No
licenses/certifications are required in this position.TRAVEL
REQUIREMENTS:Time commitment expected for travel is approximately
25% - 50% domestic and international.What Takeda can offer
you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial
Planning & Stability: 401(k) with company match and Annual
Retirement Contribution PlanHealth & Wellness programs including
onsite flu shots and health screeningsGenerous time off for
vacation and the option to purchase additional vacation
daysCommunity Outreach Programs and company match of charitable
contributionsFamily Planning SupportFlexible Work PathsTuition
reimbursementMore about us:At Takeda, we are transforming patient
care through the development of novel specialty pharmaceuticals and
best in class patient support programs. Takeda is a patient-focused
company that will inspire and empower you to grow through
life-changing work. Certified as a Global Top Employer, Takeda
offers stimulating careers, encourages innovation, and strives for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.This position is currently
classified as "hybrid" in accordance with Takeda's Hybrid and
Remote Work policy.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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Director Global Evidence & Outcomes, Executive , Cherry Hill, New Jersey
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