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.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.
- 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.
- 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
LICENSES/CERTIFICATIONS:No licenses/certifications are required in this position.
TRAVEL REQUIREMENTS:Time commitment expected for travel is approximately 25% - 50% domestic and international.What Takeda can offer you:
More about us:
- 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 reimbursement
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.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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, MAWorker Type