Director, Global Evidence & Outcomes

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OBJECTIVES: 

Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. This role is responsible for the execution of evidence generation strategies through the design, implementation, analysis and communication of real-world evidence (observational) studies including epidemiological and outcomes research studies. It will assist in driving the strategic development and execution of the use of epidemiologic data in decision making for both commercial and research and development purposes.

Key position objectives are to:

• Lead the design, conduct, analyses, interpretation and communication of real-world evidence studies including complex epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization across the product lifecycle in alignment with product evidence generation plans.
• Inform and collaborate in the design and conduct of observational/epidemiological studies to support clinical development of Takeda products, including development of external comparisons.
• Work with subject matter experts to select, develop, validate, and interpret clinical outcome endpoint(s) as appropriate for clinical development programs and other evidence generation programs.
• Collaborate and partner internally with the GEO product lead and other functions to ensure GEO studies under responsibility are aligned with product strategy and evidence generation plans and with other Takeda teams within a multi-disciplinary framework to meet study needs.
• Communicate scientific findings to internal and external audiences as effectively as possible.

ACCOUNTABILITIES: 

• Collaborates with GEO colleagues and key internal stakeholders to ensure priorities and strategies are aligned.
• Contributes to the development and lead the execution of plans addressing unmet evidentiary and patient-centered needs and product value to regulators, HTA/payers, health care providers and patients.
• Works with a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies strategy/plan for one or more therapies in an assigned therapeutic area. (e.g., works as a product lead and as a member of the GPT, integrated evidence generation sub teams, and/or other cross-functional teams/ sub-teams with manager supervision)
• Strong basis to implement strategies to describe the epidemiological characteristics of a disease including incidence and prevalence, unmet need and factors which influence changes in disease patterns.
• Effectively manages 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.
• Provides input into clinical development, regulatory, reimbursement documents.
• Performs/manages, as appropriate, relevant research activities which may include, but not limited to:
  • Design, conduct, analyses, interpretation, and communication of real-world evidence studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, observational/epidemiological research using existing data and/or collecting new data, development of external comparators that may include pre-existing data to support clinical development programs and predictive models/algorithms.
• Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports.
• Familiarity with software for management and analysis of data.
• Follows best practices for data collection, conduct and reporting of real-world evidence and clinical outcome studies.
• Compliance with all policies and regulations for quality and disclosure
• Accountable for project(s) contract/budget management.
• Reviews and develops scientific reports reflecting ongoing or completed work.
• Effectively communicates scientific findings internally and externally in conference presentations, publication and other communication mechanisms.
• Networks 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.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

• Combination of academic training and practical experience 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 epidemiology, health services research, health outcomes research, pharmacy administration, public health, economics, statistics or decision sciences, plus 5 years practical experience depending on level of position.
  • Masters degree (e.g. M.S., M.Sc., M.P.H) in a related discipline (as noted above), plus 7 years practical experience. 
• Practical experience (number of years as noted above) in performing epidemiology and outcomes research in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
• Strong technical expertise required in design and conduct of observational studies and time to event analyses,as well as the scientific communication of study findings.
• Demonstrated experience in conducting or interpreting statistical analysis.
• Experience in conducting research in different geographic regions and interacting with regulators and/or HTA/payer, policy makers.
• Ability to work collaboratively and effectively in a multicultural and cross functional team environment is expected.
• Ability to work in a global environment, independently as well as in a team and to manage multiple projects to tight deadlines with strong orientation to detail.
• Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
• Record of high-quality, peer-reviewed publications is preferred.

LICENSES/CERTIFICATIONS:

No licenses/certifications are required in this position.

TRAVEL REQUIREMENTS:

Time commitment expected for travel is approximately 10 -30% domestic and international.

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 reimbursement

More 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $156,800 to $224,000, based on candidate professional experience level.  Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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 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.

Boston, MA

Employee

Regular

Full time

About the Company:
Takeda Pharmaceutical

Salary : $156,800 - $224,000