Talent.com
Director, Global Evidence & Outcomes
Director, Global Evidence & OutcomesTakeda Pharmaceuticals • Boston, MA, US
Director, Global Evidence & Outcomes

Director, Global Evidence & Outcomes

Takeda Pharmaceuticals • Boston, MA, US
11 hours ago
Job type
  • Full-time
Job description

Global Evidence And Outcomes

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 communicates 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.
  • 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.

    Create a job alert for this search

    Director Global • Boston, MA, US

    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: 13 days ago • Promoted
    Senior Director, Global Value, Access & Pricing

    Senior Director, Global Value, Access & Pricing

    SpringWorks Therapeutics • Boston, MA, US
    Full-time
    About SpringWorks Therapeutics : .SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of...Show more
    Last updated: 15 days ago • Promoted
    Director, Real World Evidence (RWE) Statistical Lead

    Director, Real World Evidence (RWE) Statistical Lead

    Servier Group • Boston, MA, United States
    Full-time
    Select how often (in days) to receive an alert : .Type of Contract : Full-time Employment / Unlimited.Director, Real World Evidence (RWE) Statistical Lead. Boston-based, commercial-stage biopharmaceuti...Show more
    Last updated: 30+ days ago • Promoted
    Director, Global Value & Access Strategy

    Director, Global Value & Access Strategy

    GQR • Boston, MA, US
    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...Show more
    Last updated: 7 days ago • Promoted
    Senior Director, Real World Evidence (RWE) / Health Economics and Outcomes Research (HEOR)Waltham, Massachusetts

    Senior Director, Real World Evidence (RWE) / Health Economics and Outcomes Research (HEOR)Waltham, Massachusetts

    Kailera Therapeutics, Inc. • Waltham, MA, US
    Full-time
    Senior Director, Real World Evidence (RWE) / Health Economics And Outcomes Research (HEOR).At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people t...Show more
    Last updated: 30+ days ago • Promoted
    Director, External Audit Engagement

    Director, External Audit Engagement

    Fidelity Investments • Boston, MA, United States
    Full-time
    The Fidelity Enterprise Cybersecurity Governance, Risk and Compliance (GRC) Product Area is seeking a Director, External Audit Engagement to lead engagements with independent third-party audit firm...Show more
    Last updated: 28 days ago • Promoted
    Director, Search and Evaluation New Areas

    Director, Search and Evaluation New Areas

    Biogen • Cambridge, MA, US
    Full-time
    Corporate Development Search & Evaluation Director For New Rare Diseases.Corporate Development leads the establishment of Biogen's corporate strategy and is responsible for the identification, asse...Show more
    Last updated: 8 days ago • Promoted
    Director, External Audit Engagement

    Director, External Audit Engagement

    Fidelity Investments Inc. • 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
    Senior Director, Clinical Operations

    Senior Director, Clinical Operations

    Scholar Rock • Cambridge, MA, US
    Full-time
    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biolo...Show more
    Last updated: 14 days ago • Promoted
    Global Operations Director

    Global Operations Director

    Amphenol TCS • Nashua, NH, US
    Full-time
    Amphenol High Speed Products Group is the market leader for high speed, high bandwidth electrical connectors for the Telecom / Datacom market (Mobile Networks, Storage, Servers, Routers, Switches, et...Show more
    Last updated: 30+ days ago • Promoted
    Director, Global Launch Excellence

    Director, Global Launch Excellence

    LanceSoft • Cambridge, MA, US
    Full-time
    Director, Global Launch Excellence (Global Launch Excellence Lead).Location : Cambridge, MA 02139 - Hybrid.Duration : 12 Months 8 AM to 5 PM Hybrid - 2-3 Days Per Week. Top Skills Needed : Drug Launch ...Show more
    Last updated: 29 days ago • Promoted
    Global Operations Director

    Global Operations Director

    Boston IVF • 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: 11 hours ago • Promoted • New!
    Associate Director, Strategic Initiatives and Business Operations

    Associate Director, Strategic Initiatives and Business Operations

    Alloy Therapeutics • Waltham, MA, US
    Full-time
    Through a community of partners, we democratize access to pre-competitive tools, technologies, services, and company creation capabilities that are foundational for discovering and developing thera...Show more
    Last updated: 30+ days ago • Promoted
    Director Research & Development

    Director Research & Development

    Spindrift • Newton, MA, US
    Full-time
    At Spindrift, we’re making every beverage a positive force of nature.Founded in 2010, we believe the best flavors come directly from nature. That’s why every Spindrift beverage is made t...Show more
    Last updated: 9 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: 2 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: 14 days ago • Promoted
    Director, Global Compensation & Benefits

    Director, Global Compensation & Benefits

    Norstella • Boston, MA, United States
    Full-time
    Director, Global Compensation & Benefits.Location : Remote, United States.At Norstella, our mission is simple : to help our clients bring life-saving therapies to market quicker—and help patients in ...Show more
    Last updated: 30+ days ago • Promoted
    Director, Global Insights Lead, Lupus

    Director, Global Insights Lead, Lupus

    Biogen • Cambridge, MA, US
    Full-time
    Director, Global Insights Lead, Lupus.The Director, Global Insights Lead, Lupus role plays a vital part in shaping the direction of the business and contributing to brand success.It directly suppor...Show more
    Last updated: 30+ days ago • Promoted