Summittherapeutics
Director, Clinical Scientist
Remote (US). Posted a month ago
The role
The Director, Clinical Scientist leads and contributes to the design and execution of hematology/oncology clinical studies. This role partners with clinical operations, translational, and matrix teams to author regulatory documents and interpret clinical data.
What you will do
- Leads or contributes to study design and amendments with scientific stakeholders
- Collaborates with MD, regulatory and internal partners to author protocols and regulatory filings
- Collaborates with clinical operations, data management and CRO to implement data quality plans
- Leads internal medical data review and safety trend analysis
- Acts as point-of-contact for clinical inquiries from CRO medical monitor and stakeholders
- Develops input for clinical presentation slides and materials for meetings
- Partners with clinical operations and CRO to develop study start up documents
- Participates in safety meetings and reviews documentation for potential safety events
- Leads development of communication strategies for studies including KOL interactions and publications
- Writes and reviews abstracts, posters, and content for scientific meetings
Required qualifications
- MS (or equivalent)
- 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
Nice to have
- PhD
- PharmD
- MD
Benefits
- bonus
- stock
- benefits
About the company
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.