Talent.com
Director, Global Evidence & Outcomes
Director, Global Evidence & OutcomesTakeda • Boston, MA, United States
Director, Global Evidence & Outcomes

Director, Global Evidence & Outcomes

Takeda • Boston, MA, United States
4 days ago
Job type
  • Full-time
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 Description

OBJECTIVES :

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.

Key position objectives are to :

  • Contribute to product strategy thorough membership on matrix teams and through interactions with cross‑functional partners.
  • Provide real‑world evidence and patient‑centered value leadership and consultative expertise for Takeda product(s) under responsibility from early development through launch and commercialization.
  • Lead the integrated evidence generation sub‑team for products under development and develop the integrated evidence generation plan. This is a cross‑functional team with global, regional and local members from R&D and commercial.
  • Lead the development, execution, and communication of real‑world evidence and COA strategies to support regulatory submissions, product labelling, access and commercialization.
  • Communicate findings from these studies to relevant internal and external audiences as effectively as possible.
  • May manage a small team depending on size of global programs / disease areas.

ACCOUNTABILITIES :

  • Work with a multidisciplinary, matrixed organization, to ensure product priorities and strategies are aligned to meet evidentiary requirements / needs and support compelling product value propositions.
  • Collaborate and partner with product teams / sub‑teams to inform program strategy and plans and to prepare for internal governance reviews / decisions.
  • Assess and identify value evidence requirements / needs from internal and external stakeholders (patients, healthcare providers, regulators, HTAs / payers, and other decision makers) from early development through launch and commercialization of Takeda products under responsibility.
  • Lead the integrated evidence generation sub‑team for products under development, and working with global, regional and local cross‑functional colleagues lead the development of the integrated evidence generation plan. Ensure local evidence needs are met in line with product strategy.
  • Lead, develop and execute successful GEO strategies and plans to support evidence needs as defined in the integrated evidence generation plan, clinical development plans and / or regulatory strategies including, but not 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.
  • Ensure scientifically robust evidence generation activities are integrated into the development program evidence generation plans.
  • Effectively manage 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.
  • Provide input into clinical development plans, regulatory documents with accuracy and scientific integrity as well as into commercial and access / reimbursement activities and documents.
  • Prepare and / or review clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports reflecting ongoing or completed work.
  • Effectively communicate study findings to internal and external audiences, and as appropriate in conference presentations, publications, and dossiers / documents to regulators and / or other authorities.
  • 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.
  • Compliance with all policies and regulations for quality and disclosure.
  • Accountable for product annual plan budget and contract / budget management.
  • EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS :

  • 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 8+ years practical experience. Masters degree in a related discipline (as noted above), plus 10+ years practical experience.
  • Practical experience (years 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.
  • Regulator and / or HTA / payer policy‑makers.
  • Drug development experience is required and launch experience is desirable.
  • Demonstrated experience in the conduct of complex observational and / or COA studies, and the interpretation and communication of study findings to internal and external audiences. Employs advanced technical expertise to solve research questions / problems.
  • Familiarity with the role and importance of observational research in the multi‑disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is expected.
  • Ability to understand regulatory and HTA / payer challenges for Takeda products as well as interacting with regulators, HTA / payers and / or other decision makers is highly desirable.
  • Ability to work collaboratively and effectively in a multicultural and cross functional team environment is expected.
  • Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is very required.
  • Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
  • Record of high‑quality, peer‑reviewed publications is preferred.
  • Networking, communication and influencing skills. Ability to lead cross‑functional teams.
  • Excellent process and project management skills including the ability to manage multiple complex research studies.
  • Ability to influence without authority, particularly individuals at senior levels.
  • TRAVEL REQUIREMENTS :

    Time commitment expected for travel is approximately 25% - 50% domestic and international.

    Takeda Compensation and Benefits Summary

    We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    For Location : Boston, MA

    U.S. Base Salary Range :

    $174,500.00 - $274,230.00

    The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

    U.S. based employees may be eligible for short‑term and / or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

    EEO Statement

    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.

    Locations

    Boston, MA

    Worker Type

    Employee

    Worker Sub‑Type

    Regular

    Time Type

    Full time

    Job Exempt

    YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

    #J-18808-Ljbffr

    Create a job alert for this search

    Director Global • Boston, MA, United States

    Related jobs
    Director – Enterprise Continuous Improvement (ECI)

    Director – Enterprise Continuous Improvement (ECI)

    Fynetra • Boston, MA, United States
    Full-time
    Director – Enterprise Continuous Improvement (ECI).Our client is a global investment firm with offices worldwide and a collaborative, entrepreneurial culture, the firm continues to deliver value fo...Show more
    Last updated: 30+ days ago • Promoted
    Director, Operational Excellence

    Director, Operational Excellence

    Xometry • Waltham, MA, US
    Full-time
    Xometry (NASDAQ : XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives ma...Show more
    Last updated: 5 days ago • Promoted
    Senior Director, Audits, Inspections, & QMS

    Senior Director, Audits, Inspections, & QMS

    Alnylam Pharmaceuticals • Cambridge, MA, United States
    Full-time
    Reporting to the SVP, Head of Quality Assurance & Quality Control, this is an enterprise leadership role and is responsible for providing strategic and operational leadership in the planning and ex...Show more
    Last updated: 30+ days ago • Promoted
    Director, External Audit Engagement

    Director, External Audit Engagement

    Fidelity Investments • Boston, MA, United States
    Full-time
    Director, External Audit Engagement.The Fidelity Enterprise Cybersecurity Governance, Risk and Compliance (GRC) Product Area is seeking a Director, External Audit Engagement to play a leadership ro...Show more
    Last updated: 30+ days ago • Promoted
    Director, Quality & Equity MassHealth

    Director, Quality & Equity MassHealth

    InsideHigherEd • North Quincy, Massachusetts, United States
    Full-time +1
    The Director of Quality and Equity for MassHealth supports the Office of Clinical Affairs and MassHealth teams in the development and implementation of quality and equity programs including a broad...Show more
    Last updated: 30+ days ago • Promoted
    Director, Global Evidence & Outcomes

    Director, Global Evidence & Outcomes

    Initial Therapeutics, Inc. • Boston, MA, United States
    Full-time
    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 Tak...Show more
    Last updated: 30+ days ago • Promoted
    Senior Director - ExploR&D Business Operations and Alliance Management

    Senior Director - ExploR&D Business Operations and Alliance Management

    Eli Lilly and Company • Boston, MA, United States
    Full-time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show more
    Last updated: 9 hours ago • Promoted • New!
    Director, Global Value & Access Strategy

    Director, Global Value & Access Strategy

    GQR • Boston, MA, United States
    Full-time
    Director, Global Value Access & Strategy.Boston, MA (3 days onsite, 2 days remote weekly).Company is expanding its Global Value and Access Strategy (GVAS) team to support the launch and ongoing acc...Show more
    Last updated: 28 days ago • Promoted
    Director, Health Economics & Outcomes Research

    Director, Health Economics & Outcomes Research

    Vertex Pharmaceuticals Incorporated • Boston, MA, United States
    Full-time
    Vertex is a global biotechnology company that operates at the forefront of scientific innovation.We have brought multiple breakthrough therapies to patients with Cystic Fibrosis (CF) and advanced n...Show more
    Last updated: 4 days ago • Promoted
    Senior Director, External Innovation

    Senior Director, External Innovation

    Eisai • Cambridge, MA, US
    Full-time
    Senior Director, Head Of Us External Innovation.At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human...Show more
    Last updated: 4 days ago • Promoted
    Director, Global HEOR – Top Boston Pharma seeks Prospective Study exp. to work on 1s-in-Class “[...]

    Director, Global HEOR – Top Boston Pharma seeks Prospective Study exp. to work on 1s-in-Class “[...]

    Cornerstone Search Group • Boston, MA, United States
    Full-time
    Director, Global HEOR – Top Boston Pharma (Retained Search).Cornerstone Search Group’s HEOR / Market Access Practice is seeking a high-EQ HEOR professional for a newly created global role focused on ...Show more
    Last updated: 4 days ago • Promoted
    Global Operations Director

    Global Operations Director

    IVI RMA North America • Stoneham, MA, US
    Full-time
    Global Chief Transformation Officer.The Global Director of Operations is a strategic enabler who partners with IVIRMA’s regional COOs and CEOs to elevate operational capabilities and drive pe...Show more
    Last updated: 6 days ago • Promoted
    Senior Director, Global Omnichannel

    Senior Director, Global Omnichannel

    Alnylam Pharmaceuticals • Cambridge, MA, United States
    Full-time
    The Senior Director, Global Omnichannel will serve as a critical leader responsible for shaping, scaling, governing and sustaining best-in-class omnichannel capabilities across Alnylam.Reporting to...Show more
    Last updated: 30+ days ago • Promoted
    Senior Director, Global Value, Access & Pricing

    Senior Director, Global Value, Access & Pricing

    SpringWorks Therapeutics, Inc. • Boston, MA, United States
    Full-time
    We give it our all every day because we believe in the power of targeted oncology to change the outlook for people with cancer. Senior Director, Global Value, Access & Pricing.About SpringWorks Ther...Show more
    Last updated: 23 days ago • Promoted
    Director, Operational Excellence

    Director, Operational Excellence

    Apellis • Waltham, MA, US
    Full-time
    The Director of Operational Excellence plays a pivotal role in shaping how the Technical Operations organization executes its work—through structured project delivery, standardized methodolog...Show more
    Last updated: 30+ days ago • Promoted
    Director, RAND Pardee Center for Longer Range Global Policy and the Future Human Condition

    Director, RAND Pardee Center for Longer Range Global Policy and the Future Human Condition

    RAND Corporation • Boston, MA, United States
    Full-time +1
    In today's world of fast-paced change, good policy analysis is more vital than ever but often more difficult to provide.To help address this challenge, the Pardee Center serves as RAND's laboratory...Show more
    Last updated: 16 days ago • Promoted
    Global Evidence & Outcomes Leader — Real-World Value

    Global Evidence & Outcomes Leader — Real-World Value

    Takeda Pharmaceutical (US) • Boston, MA, United States
    Full-time
    A leading global biopharmaceutical company is seeking a qualified professional in Boston to contribute to the development of innovative therapies. The ideal candidate will have a Ph.Responsibilities...Show more
    Last updated: 15 hours ago • Promoted • New!
    Flagship Pioneering | Boston, MA; Cambridge, MA USA Senior Director, Strategy and Operations

    Flagship Pioneering | Boston, MA; Cambridge, MA USA Senior Director, Strategy and Operations

    Flagship Pioneering • Boston, MA, United States
    Full-time
    Senior Director, Strategy and Operations.Boston, MA USA; Cambridge, MA USA.Flagship Pioneering is a company that creates companies, building ground-breaking platforms that change the world.We are a...Show more
    Last updated: 9 hours ago • Promoted • New!