Senior Clinical Outcomes Assessment (coa) Lead

Sanofi

Cambridge, MA, US
Base: $178,500.00 - $257,833.33; bonus/equity: not...
Onsite
5+ years coa experience in pharma or cro
Expertise in psychometrics and qualitative research
Knowledge of fda and ema regulatory environments
The Senior Clinical Outcomes Assessment Lead is accountable for defining COA endpoint strategies and ensuring alignment with external standards like PFDD

Job Summary

  • The Senior Clinical Outcomes Assessment Lead is accountable for defining COA endpoint strategies and ensuring alignment with external standards like PFDD.
  • This role involves active participation in regulatory dynamics, providing guidance on Core Outcomes Sets, and representing the team in FDA meetings.
  • Sanofi offers a supportive environment with opportunities for career growth, including high-quality healthcare benefits and at least 14 weeks of gender-neutral parental leave.

Matching Summary

The Senior Clinical Outcomes Assessment Lead is accountable for defining COA endpoint strategies and ensuring alignment with external standards like PFDD.

Salary

Base: $178,500.00 - $257,833.33; Bonus/Equity: Not specified; Benefits: High-quality healthcare, wellness programs, 14 weeks parental leave

Skills & Requirements

Must-have

  • 5+ years COA experience in Pharma or CRO
  • Expertise in psychometrics and qualitative research
  • Knowledge of FDA and EMA regulatory environments
  • Experience with disease conceptual model development
  • Ability to lead cross-functional strategic initiatives

Nice-to-have

  • Track record of scientific publications in COA
  • Appetite for innovation and change management
  • Experience representing teams in consortia like C-Path
  • Strong coaching and mentoring capabilities

Key Requirements

  • Advanced academic degree (Doctorate or Master's)
  • 5+ years relevant experience in Clinical Outcome Assessments
  • Proven track record in COA data analysis or instrument validation

Work Rights

Not specified

Tailored Resume

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