Senior Director, Global Evidence and Outcomes, Rare Disease

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 7, 2022

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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At 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.Join Takeda as a Senior Director where you will contributes to the successful development and commercialization of new and innovative therapies. You will also be responsible for leading a therapeutic area (TAU) (or in some cases a major disease area within a TAU) with Global Evidence and Outcomes GEO contributing to TAU strategies through membership on matrix teams and through interactions with cross-functional leaders. This role also builds a high performing team of direct reports and provides leadership and direction to the development and implementation of real-world evidence generation and outcomes research strategies as well as tactics from development through launch and commercialization to support patients, regulatory, health care providers, payers/HTAs and/or other stakeholder evidentiary needs. As part of the Global Evidence and Outcomes team, you will report to the Head of Global Evidence and Outcomes, Rare Disease.How you will contribute:

• Collaborate and partner with Takeda teams within a multidisciplinary framework to inform TAU/disease area strategies, as well as clinical development, regulatory, commercial, evidence generation and access plans.
• Inform and communicate priorities and ensure alignment with GEO resources, strategies and tactics.
• Provide real-world evidence and patient-centered value leadership and consultative expertise for designated TAU or disease area.
• Lead GEO team in the development, execution, and communication of real-world evidence and COA strategies across TAU/disease area to support regulatory submissions, product labelling, access and commercialization.
• Lead the periodic review of GEO strategies and plans to ensure tactics are fit for purpose as a result of evolving information and multiple stakeholders needs.
• Communicate real-world evidence and outcomes strategies, and resulting findings, to internal and external audiences.
• Build, develop and manage best-in-class teams.
• Ensure team follows best-practices, policies, laws and regulations.
• Work within a multidisciplinary, matrixed organization to lead the development and execution of successful outcomes research strategies across TAU or large/complex disease area
• Represent global evidence and outcome research function at the TAU and franchise level.
• Ensure that products under area of responsibility are supported by scientifically credible, high quality evidence aligned with the needs of stakeholders responsible for approval, access/ reimbursement and use.
• Work within a multidisciplinary, matrixed organization to lead the development and execution of successful outcomes research strategies across TAU or large/complex disease area
• Represent global evidence and outcome research function at the TAU and franchise level.
• Ensure that products under area of responsibility are supported by scientifically credible, high quality evidence aligned with the needs of stakeholders responsible for approval, access/ reimbursement and use.
• Work within a multidisciplinary, matrixed organization to lead development and creation of successful outcomes research strategies.
• Overall responsibility for assuring GEO evidence generation plans and COA strategies are fit for purpose and aligned with TAU strategies.
• Ensure team partners with global, regional, local R&D and commercial functions to inform the development of integrated evidence generation plans and execution.
• Oversee the execution of research portfolio that includes the design, execution and communication of real-world evidence and clinical outcomes assessment (COA) studies.
• Oversee, and ensure high quality of, relevant research activities which may include, but not be 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.
  • Review and ensure the quality of research protocols, statistical analysis plans (SAPs), and reports.
  • Build strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • 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 COAs.
  • Maintain an up-to-date awareness of regulatory and HTA requirements/ considerations that may impact planning for and implementation of GEO strategies/ programs.
  • Build, develop, and manage best-in-class team to develop and execute pre-launch, launch, and post-launch GEO strategies and tactics to support the value of Takeda products.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Budgeting and forecasting and maintenance of an accurate budget for GEO TAU.
  • Compliance with all policies and regulations for quality and disclosure.What you bring to Takeda:
    • Advanced degree 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, is required
    • 10+ years Practical experience in performing epidemiology and outcomes research and/or COAs, in any setting, including life sciences company, research organization, academic institution or governmental agency.
    • Experience in leading real-world studies COA research in different geographic regions.
    • Knowledge and experience in management of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is expected. Clinical development experience and launch of global products is required.
    • Record of high-quality, peer-reviewed publications is preferred.
    • Knowledge of key stakeholder evidentiary needs/requirements and translating those needs into research questions.
    • Experience interacting with regulators and/or HTA/payer and/or policy makers is required.
    • Understanding of legal and regulatory issues impacting outcomes and COA labeling/promotional claims
    • Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is expected.
    • Proven ability to work collaboratively and lead effectively in a multicultural and cross functional team environment is expected.
    • Demonstrated ability to communicate scientific evidence, with strong written and verbal presentation skills, in a persuasive way.
    • Committed to delivering high quality results, overcoming challenges, and proposing solutions.
    • Demonstrated working knowledge of various health care environments globally.
    • Experience building, managing and developing effective teams.
    • Able to translate strategy into action, setting objective and delegating
    • Critical thinking strategically and tactically.
    • Ability to create and maintain an accurate budget for GEO in area of responsibility.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.Takeda 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.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. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. 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. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#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

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