Clinical Sciences Lead: Protocol Design & Study Execution

Hemab Therapeutics; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Hemab Therapeutics is seeking an Associate Director, Clinical Sciences to translate science into well-designed clinical studies and reliable evidence about how our treatments perform in patients. You will own protocol development, study execution and data review, collaborating with Medical Directors and cross-functional colleagues across clinical development.

You will lead protocol development, review data for safety and efficacy trends, and help communicate findings to internal and external

Qualifications

• Significant experience in clinical science or clinical research within drug development, including direct involvement in interventional clinical studies.
• Experience developing clinical protocols and reviewing and interpreting clinical study data.
• A strong working understanding of ICH-GCP, clinical study design and drug development in a regulated environment.
• The ability to interpret clinical information, scientific literature and changing treatment approaches and apply it to clinical development decisions.
• Experience working closely with cross-functional colleagues and external partners, including investigators, consultants or vendors.

Responsibilities

• Drive the clinical science contribution to study design and execution, bringing clinical data and scientific thinking into development decisions.
• Lead protocol development with the Medical Director, including amendments as study needs and emerging data change.
• Review clinical study data, resolve discrepancies and identify safety or efficacy trends that need investigation or action.
• Develop 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 the study is executed as intended.
• Work with clinical development colleagues to analyse and interpret study results and build a clear picture of what the data are telling us.
• Help communicate study findings clearly to internal and external stakeholders alongside the Medical Director.
• Contribute clinical content to regulatory documents, including investigator brochures, annual safety reports, clinical study reports and registration submissions.

Skills

Clinical science

Interventional studies

Protocol development

ICH-GCP

Data review

Education

Advanced degree

Job description

Hemab Therapeutics is seeking an Associate Director, Clinical Sciences to translate science into well-designed clinical studies and reliable evidence about how our treatments perform in patients. You will own protocol development, study execution and data review, collaborating with Medical Directors and cross-functional colleagues across clinical development.

You will lead protocol development, review data for safety and efficacy trends, and help communicate findings to internal and external