This role primarily supports hematology clinical development by contributing scientific expertise to study design, protocol development, data review, and interpretation of trial results across early- and late-stage programs. The work is collaborative and matrix-based, with close partnership with medical directors and cross-functional teams to help execute clinical studies and prepare study documents. It also involves meeting participation, external stakeholder support, and quality review of clinical and regulatory materials.
Key Responsibilities
- Contribute to hematology clinical study planning, execution, and scientific interpretation across development programs.
- Collaborate with medical directors and cross-functional teams in a matrix environment.
- Develop expanded synopses and author or review protocol sections, amendments, and other clinically relevant study documents.
- Prepare or review medical monitoring plans, informed consents, SAPs, and clinical study report sections.
- Participate in program team meetings, scientific advisory boards, steering committees, and safety/data monitoring meetings.
- Support external and internal stakeholder meetings, including investigator presentations and regulatory-facing discussions.
- Review clinical data and help maintain consistent first-line data review practices and conventions across studies.
- Identify study risks and contribute mitigation strategies and process improvements.
Required
- Bachelor’s degree required.
- At least 10 years of pharmaceutical clinical drug development experience.
- Proficiency in clinical trial design, Good Clinical Practice, and clinical research methodology.
- Solid medical writing skills.
- Experience conducting global clinical trials and clinical programs.
- Basic knowledge of oncology or hematology therapeutic areas.
Preferred
- Advanced degree or equivalent education in life science or healthcare, such as PhD, PharmD, or MSc.