Patient Reported Outcomes /Clinical Outcomes Assessment Scientist - 1 year contract!

Title: Patient Reported Outcomes /Clinical Outcomes Assessment Scientist

Duration: 1 year Contract

Location: 100% remote

Salary: Up to $79/hr based on experience

Our client is a leader in the pharmaceutical industry. Their goal is to unite science, technology and talent to get ahead of disease.

Please send your resume to [email protected]

The Patient Centered Outcome team plays an integral role in the development of integrated evidence plans to ensure that strong PRO/COA strategies support a patient-centric understanding of our drug development. Their mission is to implement strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers, and regulators. The team has educational backgrounds across a range of PRO/COA disciplines and experience in pharmaceutical, regulatory, and academic settings. They work in close partnership across company functions including clinical development, regulatory affairs, HEOR and patient focused drug development.

The PCO team maintains a sharp focus on the value of patient-centric outcomes across the entire respiratory and immunology portfolio, vaccines and oncology. Our client works to ensure that each clinical program has a well-characterized, innovative PRO/COA strategy that is defined early in the development lifecycle and has clear plans to develop evidence that supports PRO/COA-related endpoints.

Responsibilities

• Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK’s portfolio
• Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies
• Work cross-functionally (e.g., clinical operations, biostats teams) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analyzed appropriately in clinical trials (and are accurately described in statistical analysis plans, study reports and publications)
• Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings to support GSK’s patient-centric endpoint strategies
• Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts) which present PRO-related results from clinical trials and/or PRO development and validation studies
• Maintain awareness of scientific and regulatory changes across GSKs specialty and primary care drug development programs
• Pursue ongoing learning to understand and adopt evolving methodologies and guidelines (including those from regulatory authorities) and communicate findings to cross functional groups as needed.
  
  

Qualifications

• Bachelors or Master’s degree or higher in a relevant field (e.g., Public Health, Psychology, Pharmacology, Statistics, or a related discipline).
• Minimum of 5 years of experience in clinical research, with a focus on patient-reported outcomes (PRO) and clinical outcome assessments (COA).
• Proven track record of developing and implementing PRO/COA strategies within clinical trials or observational studies.
• Experience working with regulatory bodies and understanding of the regulatory landscape related to PRO/COAs.
• Strong understanding of psychometrics, instrument development, validation, and analysis of PRO/COA measures.
• Proficiency in statistical analysis and familiarity with biostatistical methods related to clinical research.
• Excellent communication skills, both verbal and written, with the ability to convey complex concepts to diverse audiences.
• Strong collaboration skills and experience working cross-functionally with clinical operations, biostatistics, and regulatory teams.
• Up-to-date knowledge of scientific and regulatory changes in the pharmaceutical industry, particularly related to PRO/COA methodologies.
• Familiarity with current guidelines from regulatory authorities regarding patient-centric endpoint strategies.
• Strong analytical and critical thinking skills.
• Proactive and results-oriented with a passion for improving patient-centric outcomes in clinical research.
  
  

We thank all candidates for showing interest in this role; however, only retained candidates will be contacted.

For more information on our recruitment services, please visit our website www.groomassocies.com

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