Patient-Centered Outcomes Research (PCOR) Manager in US-Remote

Remote

Patient-Centered Outcomes Research (PCOR)

• Qualitative and quantitative research
• Will not be managing any one
• PRO exp will be given first priority
• Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
• Conducts literature searches and reviews
• Familiarity with PRO needed
• Familiar Patient focused drug development guidelines for FDA
• Need PRO exp
• Academic or post doc exp will be considered
• COA exp will be given more priority
• Supporting programs but will have senior oversight
  

Purpose:

• The Manager, Patient Experience Data & Strategy role within the Patient-Centered Outcomes Research (PCOR) team works independently while under the supervision of a Director to design and execute patient experience data (PED) evidence research to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial).
• He/She develops research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple products / indications.
• This research includes literature and landscape reviews, the development and validation of Clinical Outcome Assessments (COAs), and analyses of COA endpoints.
• In addition, he/she supports integration of COA measurement strategies into clinical development programs and develops high-quality documentation to summarize PED for communication in regulatory submissions.
• He/She presents research findings internally to stakeholders within Client and externally.
• In addition, the Manager builds research relationships with key external thought leaders, fostering industry research collaboration.
• The employee must conduct their work activities in compliance with all Client internal requirements and with all applicable regulatory requirements.

Responsibilities:

1. Conducts literature & landscape reviews to identify concepts of importance to patients to develop disease conceptual models
2. Identifies & evaluates existing COA tools to determine the extent to which the assessments are fit-for-purpose
3. Leads development & integration of COA measurement strategy into clinical development programs through clinical trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensures appropriate implementation of COAs on eCOA platforms in global programs
4. Leads design and execution of qualitative research, psychometric analyses, and development of new COA tools
5. Contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints
6. Develops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
7. Contributes to development of PED standards/best practices and educational resources for functions across client to drive the integration of patient voice in development programs
8. Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses

Qualifications:

1. Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
2. Professional experience and training preferred (minimum 2 years of research experience required. Work experience can include fellowship experience)
3. Firm understanding of the scientific fundamentals of COA research & measurement science
4. Ability to work collaboratively
5. Strong interpersonal skills with an ability to leverage expertise to understand, respond effectively across stakeholders
6. Demonstrated ability to manage multiple projects involving complex processes, significant budget, competing deadlines and rapidly shifting priorities
7. Strong written and verbal communication skills
8. Experience in handling delivery of services across complex environments
9. Experience in managing projects from design through execution
10. Some experience / knowledge of the pharmaceutical industry (knowledge of regulatory/compliance frameworks) and clinical trial design
11. Demonstrated initiative and strong work ethic
12. Willingness to travel as required

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