About the company
Position listed on behalf of a partner company that manages all applications. Role based in the United States.
Responsibilities
- Lead clinical study design for oncology trials in collaboration with internal teams and external stakeholders
- Develop clinical and regulatory documentation: protocols, amendments, submissions, meeting packages
- Oversee clinical data quality with Clinical Operations, Data Management, and CROs
- Provide clinical scientific guidance and resolve study-related questions
- Support study start-up and execution: informed consent forms, lab manuals, EDC materials, safety monitoring plans
- Monitor patient safety and review potential safety events
- Drive study enrollment and site engagement with investigators and CROs
- Develop scientific communications: KOL engagement, advisory boards, congresses, publications
- Prepare scientific materials: abstracts, posters, presentations
- Coordinate scientific submissions to meetings and conferences
- Interpret clinical and translational data (immunology, immuno-oncology)
- Anticipate and resolve study challenges
Requirements
- Master's degree or equivalent in a relevant scientific or healthcare discipline (PhD, PharmD, or MD preferred)
- 5+ years relevant experience (with PhD or advanced degree), including 2+ years in hematology or oncology clinical studies
- Knowledge of clinical trial design, execution, and data interpretation in oncology drug development
- Experience with clinical protocols, regulatory documentation, abstracts, posters, presentations
- Ability to analyze clinical data and interpret translational findings
- Familiarity with clinical data review, safety monitoring, data quality processes, CRO collaboration
- Excellent written and verbal communication skills
- Cross-functional collaboration and stakeholder management
- Strong scientific judgment and analytical thinking