Associate Director Global Evidence and Outcomes
Company: Takeda Pharmaceutical
Location: Maywood
Posted on: May 21, 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 DescriptionAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as an Associate Director Global
Evidence and Outcomes, in our Cambridge, MA office.At Takeda, we
are transforming the pharmaceutical industry through our
R&D-driven market leadership and being a values-led company. To
do this, we empower our people to realize their potential through
life-changing work. Certified as a Global Top Employer, we offer
stimulating careers, encourage innovation, and strive for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.Here, you will be a vital
contributor to our inspiring, bold mission.POSITION
OBJECTIVES:Global Evidence and Outcomes (GEO) contributes to the
successful development and commercialization of new and innovative
therapies. This role is responsible for the execution of GEO
strategies through the design, implementation and communication of
real-world evidence (observational) studies including
epidemiological and outcomes research studies, development of
predictive models, and/or leading the selection, development, and
validation of clinical outcomes assessment (COA) endpoints for
inclusion in clinical development and evidence generation
programsKey position objectives are to: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 form and collaborate in
the design and conduct of observational studies to support clinical
development of Takeda products, including development of synthetic
controls.Lead the selection, development, validation, and
interpretation of COA endpoint(s) as appropriate for clinical
development programs and other evidence generation programs for all
COA endpoint strategy deliverables including COA development plans,
study protocols, statistical analysis plans, scientific reports,
briefing packages, clinical study reports, and regulatory labelling
interactions.Provide technical expertise and guidance on
observational research and/or COAs.Collaborate and partner
internally with the GEO product lead and other functions to ensure
GEO studies under responsibility are aligned with product strategy
and evidence generation plans and with other Takeda teams within a
multi-disciplinary framework to meet study municate scientific
findings to internal and external audiences as effectively as
possible.POSITION ACCOUNTABILITIES: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. (e.g.,
works as a product lead and as a member of the GPT, integrated
evidence generation sub teams, and/or other cross-functional teams/
sub-teams with manager supervision)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, as appropriate, relevant research
activities which may include, but not limited to: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, development of synthetic
control arms that include pre-existing data to support clinical
development programs and predictive models/algorithms.Develops and
interprets 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.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
pliance with all policies and regulations for quality and
disclosureAccountable 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.EDUCATION, BEHAVIORAL
COMPETENCIES AND SKILLS: Combination of academic training and
practical experience 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 5+ years practical experienceMasters degree in a
related discipline (as noted above), plus 7+ years practical
experience. Practical experience (number of years as 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.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.WHAT TAKEDA CAN OFFER YOU: 401(k) with
company match and Annual Retirement Contribution PlanTuition
reimbursement Company match of charitable contributionsHealth &
Wellness programs including onsite flu shots and health
screeningsGenerous time off for vacation and the option to purchase
additional vacation daysCommunity Outreach ProgramsEmpowering Our
People to ShineDiscover more at No Phone Calls or Recruiters
accordance with the CO Equal Pay Act, Colorado Applicants Are Not
Permitted to Apply.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, Clifton , Associate Director Global Evidence and Outcomes, Executive , Maywood, New Jersey
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