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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in PRO/COA strategies, including study design, protocol development, and evidence generation in clinical development programs. Strong ability to synthesize complex evidence and communicate recommendations effectively to stakeholders.
Highest-signal resume keywords
PRO/COA Strategy DevelopmentClinical Protocol ReviewPatient-Focused Drug DevelopmentStatistical Analysis PlansEvidence Generation Planning
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study DesignProtocol DevelopmentPsychometric EvidenceInstrument SelectionContent ValidityEndpoint PositioningEvidence Gap IdentificationConceptual Model DevelopmentVendor OversightDissemination of Findings
Soft Skills
Clear CommunicationIndependent WorkPriority ManagementCross-Functional CollaborationStakeholder Engagement
Certifications & Qualifications
Advanced Degree in Relevant Field
Industry Keywords
PharmaceuticalBiotechnologyConsultingRegulatory SettingsImmunologyDermatologyGastroenterologyNeurologyPatient ExperienceEndpoint Strategy
About the role
Key responsibilities & impact- Develop and maintain the PRO/COA components of asset evidence strategies in partnership with asset leads
- Conduct disease, patient-experience, competitive, regulatory, and endpoint landscape reviews
- Lead fit-for-purpose PRO/COA evidence-generation studies from concept through completion, including study design, protocol development, vendor oversight, scientific interpretation, and dissemination of findings
- Develop or refine conceptual models and identify and prioritize concepts of interest
- Assess existing PRO/COA instruments for fitness for purpose and identify evidence gaps
- Support endpoint strategy development and COA evidence-generation planning
- Provide technical review and input for protocols, endpoint sections, statistical analysis plans, and related study documents
- Prepare clear recommendations, decision-support materials, and documentation for cross-functional review
- Participate as the PRO/COA subject matter expert in relevant internal and partner-facing working sessions, coordinated with the asset lead
- Support vendor engagement and oversight for discrete COA evidence-generation activities, as needed
Requirements
What you’ll need- Advanced degree in a relevant field such as outcomes research, psychometrics, epidemiology, psychology, public health, or a related discipline
- Approximately 8 or more years of relevant PRO/COA experience in pharmaceutical, biotechnology, consulting, or regulatory settings
- Demonstrated experience developing PRO/COA strategies for clinical development programs, preferably including early development
- Strong knowledge of patient-focused drug development, instrument selection, content validity, psychometric evidence, meaningful-change interpretation, and endpoint positioning
- Experience reviewing clinical protocols, statistical analysis plans, and regulatory or evidence-planning documents
- Ability to synthesize complex evidence and communicate clear recommendations to cross-functional stakeholders
- Demonstrated ability to work independently, manage competing priorities, and operate effectively in a matrixed and co-development environment
- Experience in immunology, dermatology, gastroenterology, or neurology is desirable but not required