Director, Clinical Sciences – Study Strategy & Data

Hemab Therapeutics; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Hemab Therapeutics is seeking a Director of Clinical Sciences to turn scientific insights into well-designed clinical studies and clear evidence of treatment efficacy and safety. You will own protocol development, study execution and data interpretation across regulatory and cross-functional teams.

In this role, you will lead study strategy, review data for safety and efficacy, and shape regulatory documents while guiding investigators and vendors to ensure studies meet the intended design and

Qualifications

• Substantial clinical science or clinical research experience in drug development.
• Experience developing clinical protocols and interpreting safety and efficacy data from interventional studies.
• Strong working knowledge of ICH-GCP, clinical study design and drug development in a regulated environment.
• Scientific judgement to interpret clinical information, literature and changing treatment approaches and apply it to study and development decisions.
• Experience working effectively with investigators, vendors and cross-functional clinical, medical and regulatory colleagues.

Responsibilities

• Lead the clinical science contribution to study strategy, design and execution, keeping the scientific questions and patient needs at the centre of decisions.
• Drive protocol development with the Medical Director, including amendments as emerging data or study needs require.
• Own the scientific review of clinical study data, identify discrepancies and trends, and turn emerging safety and efficacy data into clear questions and actions for the team.
• Shape study documents and plans, including informed consent forms, eCRFs, medical monitoring plans and data review plans.
• Guide sites and vendors on protocol requirements, eligibility criteria and participant management so studies are executed consistently and to the intended design.
• Partner across clinical development to analyse and interpret study results and build a clear understanding of what the data mean.
• Translate study findings for internal and external audiences alongside the Medical Director.
• Develop clinical content for regulatory documents, including investigator brochures, annual safety reports, clinical study reports and registration submissions.

Skills

Clinical trial management

Protocol development

ICH-GCP knowledge

Data interpretation

Cross-functional collaboration

Education

Advanced scientific/clinical degree

Job description

Hemab Therapeutics is seeking a Director of Clinical Sciences to turn scientific insights into well-designed clinical studies and clear evidence of treatment efficacy and safety. You will own protocol development, study execution and data interpretation across regulatory and cross-functional teams.

In this role, you will lead study strategy, review data for safety and efficacy, and shape regulatory documents while guiding investigators and vendors to ensure studies meet the intended design and