(Senior) Principal - Clinical Outcome Assessment Science - Multiple locations
HybridBerlin, State of Berlin, Germany
Job Summary
Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects. Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions, supporting preparation for FDA meetings as the COA subject matter expert. Lead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches, while overseeing qualitative research activities supporting content validity. Serve as a trusted advisor to pharmaceutical and biotechnology sponsors, translating emerging scientific and regulatory expectations into actionable client recommendations. Mentor and coach COA scientists and consultants, ensuring internal scientific quality and best practices in project delivery.
Required Qualifications
- Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research
- Extensive experience developing COA endpoint strategies across multiple therapeutic areas
- Hands-on experience developing new COA instruments, including item writing and qualitative validation
- Strong experience supporting FDA-facing endpoint strategy and regulatory interactions
- Proven ability to lead, mentor, and oversee multidisciplinary scientific teams
- Excellent scientific writing, presentation, and stakeholder engagement skills
- Well-developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing
- An entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same
- Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline
- Strong publication record and recognized credibility in outcomes research or COA measurement science
Desired Qualifications
- Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred
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