Summary
Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Clinical Outcomes Assessment Scientist who will serve as the lead for individual projects in support of clinical development programs.
This consultant will report to the Director of Health Outcomes, and work with cross-functional teams. The Clinical Outcomes Assessment Scientist will develop elements of a COA evidence strategy across the product life cycle in alignment with applicable regulatory guidance (eg, FDA, EMA), payer/HTA needs, and under consideration of patient-centricity principles.
The Clinical Outcomes Assessment Scientist supports the development and execution of a comprehensive, and scientifically rigorous global Clinical Outcomes Assessment (COA) strategy (ie, patient-reported, clinician-reported, observer-reported outcomes, performance measures, digital health technologies), including but not limited to:
gap identification that is aligned with the clinical, regulatory, commercial, and market access strategies for development assets,selection/development and implementation of COA tools in clinical development programs as clinical trial endpoint measures, andendpoint measure use (or mitigation via other patient experience data collection) in demonstrating the value of client's products to multiple stakeholders (eg, regulators, payers, clinicians, and patients).Qualifications/Experience:
Education:
- Bachelor's degree required
- Masters in Life Sciences, outcomes research, health services research, epidemiology, public health, or community health preferred.
Experience:
- 3+ years of managing COA development and validation projects
- Technical competency in the use of eCOA/ePRO and its implementation, and linguistic validation of COA measures as well as an understanding of psychometrics and related statistics
- Excellent knowledge of clinical development and research study designs and interpretation
- Good understanding of qualitative and quantitative approaches applicable to patient insights, feelings, and functioning
- Effectiveness in a scientific advisory role involving both strategic and tactical elements
- Experience partnering and collaborating with external vendors
- In-depth professional or expert knowledge of COA frameworks and its application to pharmaceutical development at an international level
- Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages.
- Knowledge of international healthcare systems and their changing needs for COA information
- Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling, and promotional claims
- In-depth knowledge of DEA regulations and international controlled substance laws (e.g., UN Conventions, EU regulations).
- Proven track record of working with novel chemical entities (NCEs) and navigating the complexities of their regulatory status.
Term & Start
- Fully Remote – 30% travel (conferences, various corporate locations, and stakeholder meetings, including overnight trips)
- 12-month contract, with possible extension
- 2 Video Interviews - Start 2-3 weeks from an offer
- Benefits Available (Medical, Dental, Eye)