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Director, Clinical Scientist
Summit Therapeutics, Inc.. Lead/contribute to study design and amendments with internal and external scientific stakeholders .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical study design, regulatory documentation, and data quality management, with a strong focus on oncology and immuno-oncology. Proficient in developing communication strategies and materials for diverse stakeholders in clinical research.
Highest-signal resume keywords
Clinical Study DesignOncology/Hematology ExperienceRegulatory SubmissionsData Quality ManagementCommunication Strategy Development
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 Data ReviewSafety Trend AnalysisProtocol DevelopmentStatistical AnalysisScientific Writing
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationCollaborationStakeholder Engagement
Tools & Technologies
EDCLab ManualSafety Monitoring PlanICF
Certifications & Qualifications
MSPhDPharmDMD
Industry Keywords
ImmunologyImmuno-OncologyClinical TrialsKOL InteractionsAdvisory Boards
About the role
Key responsibilities & impact- Lead/contribute to study design and amendments with internal and external scientific stakeholders
- Collaborate with MD, regulatory, and internal partners on protocols, amendments, regulatory filings, and documentation
- Develop and implement data quality plans and lead medical data review and safety trend analysis
- Serve as point of contact for clinical inquiries from CRO medical monitors and stakeholders
- Develop clinical presentation slides and communications for meetings, site visits, training, newsletters, and study sites
- Develop and maintain study startup documents and resources, including ICF, Lab Manual, EDC, and Safety Monitoring Plan
- Participate in safety meetings and review potential safety events
- Develop communications strategies for studies, including KOL interactions, advisory boards, medical meetings, publications, and events
- Write or review abstracts, posters, scientific meeting content, presentations, and publicly distributed materials
- Coordinate submissions to scientific meetings and appropriate venues
- Write clinical science sections of meeting packages and support clinical documentation for regulatory submissions
- Perform other duties as assigned
Requirements
What you’ll need- MS (or equivalent) required; PhD, PharmD, or MD preferred
- Minimum of 5+ years overall related experience with PhD or like degree
- Minimum of 2+ years’ experience in conducting / supporting oncology/hematology clinical studies
- Excellent written and verbal communication skills
- Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
Benefits
Comp & perks- Potential bonus
- Stock
- Benefits
- Variable compensation may be included in the total compensation package
- Equal Opportunity Employer