FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research and development, with a strong focus on regulatory compliance and trial execution. Proficient in drafting clinical documents and conducting literature research to support study design and safety analysis.
Highest-signal resume keywords
Clinical Research ExperienceRegulatory Document DraftingFDA ComplianceClinical Trial ManagementCritical Thinking
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study DesignProtocol DevelopmentData AnalysisMedical MonitoringLiterature ResearchRisk Mitigation StrategiesStatistical AnalysisSafety Narrative WritingIND/IMPD SubmissionsFirst-In-Human Studies
Soft Skills
Effective CommunicationCollaborationDecision-MakingPresentation SkillsTraining and Mentoring
Certifications & Qualifications
PhDPharmDMaster’s Degree in Biomedical Subject
Industry Keywords
Clinical GeneticsBiotechnologyPharmaceuticalGCP GuidelinesEMEAICHStudy ReportsAdvisory BoardsData Safety Monitoring BoardsInvestigator Queries
About the role
Key responsibilities & impact- Represent the clinical genetics medicine function on study teams
- Contribute medical and scientific expertise to compliant, high-quality trial execution
- Contribute to Clinical Study Concepts, protocols, and amendments
- Conduct literature research on indication selection, rationale, and endpoints
- Draft clinical sections of regulatory and clinical documents, including briefing books, IND/IMPD submissions, investigator’s brochures, consent forms, and study reports
- Review medical monitoring plans, statistical analysis plans, and data management materials
- Partner with Clinical Trial Managers to provide day-to-day clinical input
- Train study team and CRO personnel on clinical aspects of trials
- Support medical monitoring, investigator queries, safety narratives, and safety and efficacy trend analysis
- Organize steering committees, advisory boards, data safety monitoring boards, and consultations with global subject matter experts
- Identify program, trial, and data risks and implement mitigation strategies
- Ensure compliance with FDA, EMEA, ICH, and GCP guidelines
Requirements
What you’ll need- Bachelor’s degree and 8+ years of clinical research/development experience
- Training as a scientist in the pharmaceutical or biotechnology sector, or in an academic or clinical setting
- Effective verbal and written communication and presentation skills
- Ability to work productively in a fast-paced, collaborative environment
- Demonstrated or potential critical thinking skills and sound decision-making
- Preferred: PhD, PharmD, or Master’s degree in a biomedical subject
- Preferred: Experience in early-phase development, including First-In-Human and Proof of Concept studies
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required