Job Title: Director/Senior Director, Clinical Scientist (Hematology, Early Phase)

Work Location: Remote-EST or CST

Summary:

This position provides scientific leadership for early-phase clinical trials in hematology, focusing on first-in-human studies. The role involves collaboration with cross-functional teams to ensure successful trial execution and data interpretation, with an emphasis on advancing innovative biologics for hematologic disorders.

Responsibilities:

• Lead scientific oversight and execution of Phase 1 dose-escalation trials in hematologic disorders, including study design and data interpretation.
• Develop and review essential clinical documents such as protocols, amendments, investigator brochures, eCRFs, and statistical analysis plans.
• Guide dose-escalation and study conduct by analyzing emerging safety, pharmacokinetic/pharmacodynamic, and biomarker data in real time.
• Collaborate with cross-functional teams including Clinical Operations, Translational Medicine, Regulatory, Biometrics, and Safety to maintain study progress.
• Provide scientific leadership during data review meetings, governance forums, and interactions with investigators and external partners.
• Ensure timely preparation of regulatory briefing materials and support regulatory interactions as needed.
• Drive the authorship and review of clinical and regulatory documents, ensuring clarity and scientific rigor.
• Translate complex scientific findings into actionable recommendations for internal and external stakeholders.

Qualifications:

• PhD, PharmD, MD, or equivalent advanced scientific degree required.
• Strong scientific background in hematology.
• Experience leading or supporting early-phase (Phase 1/first-in-human) clinical trials.
• Minimum of 8 years of clinical research or clinical development experience.
• Demonstrated ability to independently author clinical and regulatory documents.
• Proven analytical skills with the ability to interpret and communicate complex data.
• Experience working in fast-paced, lean environments.
• Excellent collaboration and communication skills with cross-functional teams.

Published Category: Clinical Operations & Development