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Senior Director, Epidemiology & Health Outcomes

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Senior Director, Epidemiology & Health Outcomes

  • Location:

    Boston, United States

  • Sector:

    Life Sciences

  • Contact:

    Sam O'Donoghue

  • Job ref:

    523

  • Published:

    13 days ago

  • Expiry date:

    2020-12-31

Ironwood recognizes that clinical outcome assessments (COAs) are critical for achieving product regulatory approvals, creating robust and differentiated product profiles, informing health economic assessments, and providing important information to patients and health care professionals for therapeutic decision-making. The Head of Epidemiology will be responsible for leading the development of clinical outcome assessments that are well-defined and reliable instruments for demonstrating a treatment benefit. In these efforts, the individual will collaborate with content and methodology experts within the organization and retain external expertise, as needed, to meet the needs of key stakeholders. This role also supports the development of patient-reported outcome (PRO) strategies during clinical development and works with cross functional teams to implement those strategies. The inclusion of PROs/COAs in trials are critical for creating robust and differentiated product profiles and for providing information important for therapeutic decision-making to patients, physicians and payers. This position will report to the VP, Head of Data Science and be member of the Data Sciences leadership team.

Responsibilities:

Develop clinical outcome assessment strategies that qualify instruments for the context of use necessary to meet the target product profile, including the development of “fit for purpose” instruments when necessary.

Ensure that instruments for Ironwood’s development programs reflect outcome measurement best practices and meet the needs of key stakeholders.

Contribute to selection, development, and implementation of instruments used in clinical trials and provide input on study protocols and statistical analysis plans.

Manage budget, delivery, and relationships with external subject matter expert resources in Outcome Measurement & Study Endpoints.

Maintain up-to-date expertise in instrument development, especially as it relates to biopharmaceutical product development and regulatory science.

Establish regulatory intelligence for instrument development and study endpoint selection to support label claims in ICH regions.

Work with Medical Sciences and Information Management to develop publication plans and communication strategies for Outcome Measurement & Study Endpoint information that targets physicians, patients, payers and policy makers.

Provide ad hoc statistical analysis support as needed.

Requirements:

Advanced degree, PhD preferred, in Epidemiology, Health Economics and Outcomes Research, Psychometrics, or related discipline preferred with a minimum of 10 years professional experience (15 with Masters) in Epidemiology research as it relates to clinical pharmaceutical development, clinical outcome assessments, predominantly PROs/COAs, and/or psychometric analysis.

Working knowledge of common statistical analysis packages such as SAS or R.

Experience working directly with the FDA on the development of PROs/COAs.

Strong knowledge of and experience with instrument development and implementation of corresponding research methodology.

Experience conducting due diligence and representing the company in business partnerships in collaboration with Corporate Development, Alliance Management, and the applicable commercial colleagues.

Expertise in instrument development, especially as it relates to biopharmaceutical product development and regulatory science.

Strong oral and written communication skills, with the ability to communicate effectively to internal and external stakeholders.

Some travel required