Director, Clinical Sciences — Lead Studies & Data

Hemab Therapeutics; Cambridge (MA); On-site; USD 200,000 - 260,000; Full time

Job summary

Hemab Therapeutics in Cambridge, MA, is seeking a Director, Clinical Sciences to turn scientific findings into well-designed clinical studies and clear evidence of how our therapies perform in patients. You will own protocol development, study execution and data interpretation, working closely with Medical Directors and colleagues across clinical development, regulatory and other functions.

In this leadership role you will shape study documents, guide sites and vendors, analyze study results and

Qualifications

• Substantial clinical science or clinical research experience in drug development with direct responsibility for clinical studies.
• 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.
• The scientific judgement to interpret clinical information and apply it to study 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 patient needs at the centre of decisions.
• Drive protocol development with the Medical Director, including amendments as data or study needs require.
• Own the scientific review of clinical study data, identify discrepancies and translate data into actions for the team.
• Shape study documents and plans, including informed consent forms, eCRFs, MSPs and data review plans.
• Guide sites and vendors on protocol requirements and participant management for consistent execution.
• Partner across clinical development to analyse and interpret study results.
• Translate study findings for internal and external audiences alongside the Medical Director.
• Develop clinical content for regulatory documents (investigator brochures, safety reports, study reports, registrations).

Skills

Clinical science experience

Clinical research in drug development

ICH-GCP knowledge

Clinical study design

Cross-functional collaboration

Education

Advanced scientific or clinical degree

Job description

Hemab Therapeutics in Cambridge, MA, is seeking a Director, Clinical Sciences to turn scientific findings into well-designed clinical studies and clear evidence of how our therapies perform in patients. You will own protocol development, study execution and data interpretation, working closely with Medical Directors and colleagues across clinical development, regulatory and other functions.

In this leadership role you will shape study documents, guide sites and vendors, analyze study results and