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Director / Associate Director GI, Patient-Centered Outcomes, Global Evidence and Outcomes

Company: Takeda Pharmaceutical
Location: Mount Vernon
Posted on: November 19, 2021

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 DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director / Associate Director GI, Patient-Centered Outcomes, 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: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 GI 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.POSITION 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.
    • Represent the GEO function on corporate cross-functional teams, providing strategic input related to product development and commercialization to enable and support informed decision making.-
    • Generate patient insights about disease and treatment, and lead the development of COA measurement strategies to support clinical development, post-authorization and commercial research activities across the lifecycle of drug development with consideration for global stakeholder needs.
    • Lead strategy development and evidence generation of 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 GI COA endpoint strategies for multiple assets.
    • Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs), and reports, with a specific focus on COAs.
    • Prepare, review, and publish scientific reports reflecting ongoing or completed work
    • Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned.
    • Perform relevant research activities that may include, but not be limited to:
      • Design, execution, and analysis in whole or in part of longitudinal prospective observational or randomized clinical trials evaluating clinical, and/or patient-centered endpoints;
      • Targeted or comprehensive systematic literature reviews.
      • Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, regulatory and reimbursement dossiers and other communication mechanisms.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
        • Combination of academic training and practical experience (GI 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 (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
          • A minimum of 5 years of Patient Reported Outcomes experience is required.
          • Demonstrated experience in interpreting statistical analysis is required. Ability to communicate 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 required.
          • Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences.
          • Expertise and experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is expected.
          • Must be capable of leading teams, influencing teams, and driving decisions; must also be able to work effectively as a member of different teams.
          • Experience with the drug development process in the pharmaceutical industry is strongly preferred. Regulatory understanding and experience in negotiating PRO label claims is strongly preferred. Experience with ePRO is strongly preferred.
          • GI experience is highly desirable
          • Ability to work collaboratively and effectively in a multicultural and cross functional team environment.
          • Experience managing budgets is expected.
          • Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment is highly desirable.-
          • Experience in conducting outcomes-research in different geographic regions and interacting with regulator and/or HTA/payer policy-makers is highly desirable.TRAVEL REQUIREMENTS:
            • Time commitment expected for travel is approximately 10 - 25 %.WHAT TAKEDA CAN OFFER YOU:
              • 401(k) with company match and Annual Retirement Contribution Plan
              • Tuition reimbursement Company match of charitable contributions
              • 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 ProgramsEffective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles.- US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.This job posting excludes CO applicants.#LI-SGMEEO 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, Mount Vernon , Director / Associate Director GI, Patient-Centered Outcomes, Global Evidence and Outcomes, Executive , Mount Vernon, New York

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