Leads scientific contributions to hematology clinical studies across early- and late-stage development, helping design trials, interpret data, and maintain scientific integrity throughout the program. The role also supports related therapeutic-area work as needed, with responsibilities spanning protocol development, medical writing, data review, and stakeholder presentations. This is a cross-functional clinical development position that works closely with medical directors and other internal teams in a matrix environment.
Key Responsibilities
- Contribute to hematology clinical study strategy, design, and execution across development stages.
- Develop expanded synopses and author clinically relevant sections of protocols and amendments.
- Review and help prepare medical monitoring plans, statistical analysis plans, informed consents, and clinical study report sections.
- Participate in program team meetings, advisory boards, steering committees, and data/safety monitoring meetings.
- Review clinical data and support consistent data review practices, conventions, and medical monitoring plans.
- Prepare materials for external stakeholder meetings and present data to investigators and internal collaborators.
- Identify program risks and contribute to mitigation strategies and process improvements.
- Collaborate with medical directors and cross-functional partners to resolve comments and support regulatory documents.
Required
- Bachelor’s degree.
- At least 10 years of pharmaceutical clinical drug development experience.
- Experience with global clinical trials and clinical program execution.
- Working knowledge of Good Clinical Practice, study design, and clinical research methodology.
- Strong medical writing skills.
- Basic knowledge of hematology or oncology therapeutic areas.
Preferred
- Advanced degree in a life science or healthcare field, such as PhD, PharmD, or MSc.