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Senior Clinical Development Scientist
Gilead Sciences. Support late-stage oncology clinical development .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in late-stage oncology clinical development, including protocol preparation, regulatory compliance, and data analysis. Proven ability to lead teams, adapt to changing project needs, and communicate effectively within clinical research environments.
Highest-signal resume keywords
Oncology Clinical DevelopmentProtocol PreparationRegulatory ComplianceData AnalysisTeam Leadership
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 ResearchData ManagementRegulatory FilingsClinical Trial ExecutionScientific ReportingMultiple Myeloma ExperienceCAR-T Therapy ExperienceFDA RegulationsEMA RegulationsGood Clinical Practice
Soft Skills
Strong CommunicationOrganizational SkillsFlexibilityAdaptabilityAnalytical Abilities
Tools & Technologies
Microsoft OfficeClinical Trial Management Systems
Certifications & Qualifications
PharmDPhDMSBSRN
Industry Keywords
Clinical PharmacologyDrug Development PhasesICH GuidelinesClinical MonitoringScientific Presentations
About the role
Key responsibilities & impact- Support late-stage oncology clinical development
- Collaborate with the Clinical Scientist Program Lead on ongoing clinical trial program activities
- Collaborate on functional area activities during program implementation
- Support clinical study start-up, execution, and closeout
- Contribute to data analysis and reporting
- Support regulatory filings
- Develop study concept sheets and protocols
- Participate in protocol review discussions
- Prepare protocols, amendments, study manual sections, Investigator meeting notebooks, and other documents
- Contribute to CRFs, Data Management Manuals, and Data Analysis Plans
- Address scientific and procedural questions from Investigators
- Contribute to data listings, summary tables, study results, manuscripts, and scientific presentations
- Assist with regulatory documents
- Anticipate clinical study obstacles and implement solutions with guidance
- Coordinate teams and provide direction when requested
- Provide clinical monitoring for clinical studies or study components
- Summarize published scientific information for new study development
- Adhere to regulatory requirements, Good Clinical Practice, and Gilead SOPs
- Create inclusion, develop talent, and empower teams as a people leader
Requirements
What you’ll need- PharmD or PhD in clinical research or clinical pharmacology with scientific and/or drug development experience
- MS with 6+ years’ relevant scientific and/or drug development experience
- BS or RN with 8+ years’ relevant scientific and/or drug development experience
- Experience in Multiple Myeloma and/or CAR-T Therapy preferred
- Experience with Microsoft Office and other job-related programs
- Ability to learn quickly
- Flexibility and adaptability to change and ability to move between projects
- Proven analytical abilities through past experience and/or academic research
- Understanding of drug development phases and associated clinical trials across phases
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and standard clinical procedures
- Strong communication and organizational skills
- Ability to travel when needed
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance