Senior Clinical Outcomes Assessment (COA) Lead
$178,500–$257,833 year
On-siteCambridge, Massachusetts, United States or Morristown, New Jersey, United States
Job Summary
Define COA endpoint strategies and conduct related activities for specific programs, assets, or indications. Lead the development of disease conceptual models, selection and validation of COA instruments, and creation of briefing books for regulatory consideration. Provide strategic input to R&D, HEVA, Medical Affairs, and Commercial teams while ensuring alignment with external standards and internal priorities. Represent the COA team in FDA meetings, cross-functional initiatives, and pre-competitive consortia. Coach less experienced scientists, deliver internal educational programs, and maintain scientific quality across deliverables.
Required Qualifications
- Master's Degree in relevant field
- 5 years experience in COA in either Pharma/CRO/Academic/Consultancy settings
Desired Qualifications
- Proven track record from scientific publications in core COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation
- Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environments
- Appetite for innovation and change management
- Ability to interact and manage external and internal networks
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