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

Work Location: Suffolk County, Massachusetts

Summary:

This consulting opportunity is for an experienced clinical scientist to provide immediate scientific leadership on an early-phase hematology clinical trial. The role is contract-based, with an estimated duration of three months and the possibility of extension or transition to a permanent position. The consultant will play a key role in study design, data interpretation, and cross-functional collaboration for a first-in-human trial.

Responsibilities:

• Act as the lead Clinical Scientist for a Phase 1 dose-escalation trial in hematologic disorders, shaping study design and dose-escalation strategies.
• Develop and review essential clinical documents, including protocols, amendments, investigator brochures, eCRFs, completion guidelines, SAP TLF shells, and regulatory materials.
• Oversee real-time review and interpretation of emerging safety, pharmacokinetic/pharmacodynamic, and biomarker data to guide study conduct.
• Collaborate with cross-functional teams such as Clinical Operations, Translational Medicine, Regulatory, Biometrics, and Safety to ensure study progress.
• Lead scientific discussions in data review meetings, governance forums, and with external partners including investigators, CROs, and vendors.
• Provide expert input on clinical and regulatory documentation, ensuring clarity and compliance with industry standards.
• Support the ongoing development and execution of study-related strategies and operational plans.
• Contribute to the interpretation and communication of clinical data, offering actionable recommendations to guide decision-making.

Qualifications:

• MD, PharmD, PhD, or equivalent advanced scientific degree required.
• Extensive scientific background in hematology.
• Direct experience with early-phase (Phase 1/first-in-human) clinical trials.
• 8+ years of clinical research or clinical development experience in the life sciences sector.
• Demonstrated ability to independently author clinical and regulatory documents.
• Strong analytical skills with the ability to interpret complex scientific data and provide clear recommendations.
• Experience working in fast-paced, dynamic environments.
• Excellent communication and cross-functional collaboration skills.

Published Category: Clinical Operations & Development