Senior Director Epidemiology/Health Outcomes
- PROs/COAs | FDA Experience | GI
- Cambridge, MA
- $220 - $250,000 | 25% bonus | RSUs
A Pharmaceutical company is looking to hire a Senior Director Epidemiology/Health Outcomes. The Head of Epidemiology will be responsible for leading the development of clinical outcome assessments that are well-specified and dependable methods for exhibiting a treatment benefit. In these efforts, the individual will cooperate with substance and methodology experts within the organization and preserve outside expertise, as needed, to meet the needs of key shareholders. This role also supports the development of patient-reported outcome (PRO) strategies during clinical development and works with cross operating teams to execute those approaches. The inclusion of PROs/COAs in trials are crucial 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.
The Senior Director Epidemiology/Health Outcomes will have responsibilities that include:
- Create clinical outcome assessment strategies that qualify instruments for the context of use essential to meet the target product profile, involving the advancement of "fit for purpose" instruments when necessary.
- Guarantee that instruments for the company's development programs reflect outcome measurement best procedures and meet the needs of key shareholders.
- Impact to selection, development, and application of instruments used in clinical trials and provide input on study protocols and statistical analysis plans.
- Oversee budget, delivery, and relationships with exterior subject matter specialist resources in Outcome Measurement & Study Endpoints.
- Sustain up-to-date proficiency in instrument enhancement, especially as it relates to biopharmaceutical product development and regulatory science.
- Launch regulatory aptitude for instrument development and study endpoint selection to support label claims in ICH areas.
- Operate 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.
- Deliver ad hoc statistical analysis support as needed.
The ideal candidate will have the following skill set:
- 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.
- 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.