Associate Director, COA
Company: Takeda
Location: Cambridge
Posted on: May 23, 2023
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest 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.OBJECTIVES:
- As part of the Global Evidence and Outcomes (GEO) team, this
position is focused on documenting the patient value of Takeda's
new medicines to contribute to the successful development and
commercialization of new, innovative therapies across the oncology
portfolio through:
- Analysis of unmet clinical need and potential therapeutic
preferences
- Development of Clinical Outcome Assessment (COA) endpoint(s) as
appropriate for clinical development programs and inclusion of COA
endpoint strategy in all major deliverables such as clinical
development plans, study protocols, strategy slide decks,
statistical analysis plans, briefing packages, clinical study
reports, and regulatory labelling interactions. Ensure these
reflect the COA needs from key stakeholders, including regulators,
payers, healthcare professionals and patients
- Collaboration and alignment internally with the GEO asset lead
(if applicable) and other Takeda R&D and Business Unit teams
within a multi-disciplinary framework to meet product needs.
- Development of evidence for COA measurement strategies for
development of post-authorization and commercial research
activities supporting patient-centered needs and product value to
regulators, HTA/payers, health care providers and patients.
- Development and implementation of COA-based support tools for
patients and healthcare professionals in routine clinical practice
using digital technologies. How you will
contribute:ACCOUNTABILITIES:
- Conduct qualitative and quantitative research to inform
development on conceptual disease-models.
- Develop, assess and interpret COAs, including Patient-Reported
Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and
Clinician-Reported Outcomes (ClinROs), and performance outcome
(PerfO) measures to derive clinical benefit during the clinical
development and commercialization of new molecules, including
development and validation of PRO and health-related quality of
life instruments.
- Provide strategic input on corporate cross-functional teams
related to product development and commercialization to enable and
support informed decision making.
- Generate patient insights about disease and treatment and
inform COA measurement strategies to support development,
post-authorization and commercial research activities across the
lifecycle of drug development.
- Contribute to the strategy development and generate evidence
for COA-based support tools for patients and healthcare
professionals in routine clinical practice using digital
technologies.
- Work within a multidisciplinary, matrixed organization to
develop and execute successful Oncology COA endpoint strategies for
multiple assets.Minimum Requirements/Qualifications: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 5+
years practical experience
- Masters degree in a related discipline (as noted above), plus
7+ years practical experience.
- Practical experience in performing outcomes research required,
preferably in different geographic regions and interacting with
regulator and/or HTA/payer policy-makers
- A minimum of 3 years of Patient Reported Outcomes experience is
required.
- Demonstrated experience in interpreting statistical analysis
and communicating scientific evidence, with strong written and
verbal presentation skills, is required.
- Working knowledge of Patient Focused Drug Development (PFDD)
Guidance documents and other relevant guidance documents and best
practices is required.
- Ability to understand regulatory and HTA/payer challenges for
Takeda products; and to critically review data and assimilate
strategies that take such environments into consideration is
required.
- Familiarity with the role and importance of outcomes research
in the multi-disciplinary drug development and commercialization
environment and process (involving multiple stakeholders) is
expected.
- Ability to work collaboratively and effectively in a
multicultural and cross functional team environment.
- Demonstrated expertise in patient-reported
outcomes/health-related quality of life assessment is highly
desirable. LICENSES/CERTIFICATIONS:No licenses/certifications are
required in this position.TRAVEL REQUIREMENTS:Time commitment
expected for travel is approximately 10 - 25 %.What Takeda can
offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- Family Planning Support
- Flexible Work Paths
- Tuition 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.LOCATION:
- This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.In accordance with the
CO Equal Pay Act, Colorado Applicants Are Not Permitted to
Apply.Employees may also be eligible for Short Term and Long-Term
Incentive benefits. 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.The final salary
offered for this position may take into account a number of factors
including, but not limited to, location, skills, education, and
experience.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.LocationsCambridge, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Cambridge , Associate Director, COA, Executive , Cambridge, Massachusetts
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