Associate Director, Global Evidence & Outcomes

BioSpace; Cambridge (MA); On-site; USD 153,000 - 242,000; Full time

Job summary

A leading company in the biotechnology sector seeks an Associate Director for Global Evidence & Outcomes. This key role focuses on executing evidence generation strategies to support clinical development and commercialization of therapies, collaborating across functions, and ensuring alignment with regulatory and health authority needs.

Benefits

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid vacation and sick time

Qualifications

• 5+ years practical experience in outcomes research.
• Strong technical expertise in observational studies.
• Ability to work in a multicultural team environment.

Responsibilities

• Lead the design and conduct of real-world evidence studies.
• Collaborate with internal stakeholders for study alignment.
• Prepare and review clinical research protocols and reports.

Skills

Epidemiological research

Outcomes research

Statistical analysis

Communication

Education

PhD or equivalent in relevant discipline

Master’s degree in a related discipline

Job description

Associate Director, Global Evidence & Outcomes

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Objectives

Job Description

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 GEO strategies through the design, implementation, and communication of the value of real-world evidence (observational) studies to support the development of therapies– this includes epidemiological and outcomes research studies, leading the selection of endpoints for inclusion in both hypothesis testing and generating analysis plans to support . A key component is to contribute to evidence generation for designated assets/programs.

Key Position Objectives Are To

• Lead the design, conduct, analyses, interpretation, and communication of real-world evidence studies including epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization in alignment with product evidence generation plans.
• Inform and collaborate on the design and conduct of observational studies to support clinical development of Takeda products, including development of synthetic controls.
• Lead the selection, development, evaluation, and interpretation of clinical endpoint(s) as appropriate for asset development programs and other evidence generation programs for relevant disease areas. This may include developing statistical analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions.
• Provide expertise and guidance on observational research including the evaluation and use of clinical/molecular/genetic data sets to analysts and other cross-functional team members.
• Collaborate and partner with other key internal functions to ensure relevant GEO studies are aligned with disease and asset strategy, as well as congruent with evidence generation plans within a multi-disciplinary cross-functional setting.
• Communicate scientific findings to internal and external audiences.
  
  
  

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 within a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies, for one or more therapies in an assigned therapeutic area
• Effectively manages external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs – including 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, execution, interpretation, and communication of literature reviews (targeted, systematic etc.), meta-analyses, and indirect treatment comparisons; development of synthetic control arms to support clinical development programs and regulatory/HTA submissions. Design, execution, interpretation, and communication of real-world evidence studies such as observational research using existing data and/or collecting new data, development of synthetic control arms and predictive models/algorithms to support clinical development programs. Assessing and documenting population estimates. Execution of COA strategy/plan for a specific product(s). This includes conducting qualitative and quantitative research to inform development of conceptual disease-models; designing and executing studies in whole or in part to generate evidence on the validity of COA endpoints and developing COA evidence dossiers for regulatory submissions; conducting analyses of PRO data from clinical trials to support value messages and labelling claims.
• Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports.
• Familiarity with analytical software for management and analysis of data.
• Follows best practices for data collection, conduct and reporting of real-world evidence 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, peer-reviewed publications 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 and COAs.
  
  
  

Education, Experience, Knowledge And Skills

• A combination of academic training and practical experience in outcomes research is required. This mayconsist of: Doctoral degree (e.g., PhD, ScD, DrPH, MD, PharmD) in a relevant discipline such as, but not limited to, medicine, pharmacy, health services research, health outcomes research, economics, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 5+ years practical experience. Master’s degree in a related discipline (as noted above) plus 7+ years practical experience.
• Practical experience (number of years as noted above) in conducting research in epidemiology, health economics and outcomes, pharmacoepidemiology, Pharmacoeconomics, and/or computational biology, in any setting (including life sciences, contract research organizations, academia or governmental agency) is required.
• Strong technical expertise in the design, conduct, and interpretation of observational studies as well as the scientific communication of study findings.
• Experience in conducting research in different geographic regions
• 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.
• Records of high-quality, peer-reviewed publication is preferred.
  
  
  

Travel Requirements

Time commitment expected for travel is approximately 10 -30% 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:

Cambridge, MA

U.S. Base Salary Range

$153,600.00 - $241,340.00

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-termincentives. 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.

LocationsCambridge, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Business Development and Sales

• Industries

  Internet News

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