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