Associate Director, Clinical Sciences — Study Design & Data

Hemab Therapeutics; København; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

Hemab Therapeutics seeks an Associate Director, Clinical Sciences to translate our science into well‑designed clinical studies and robust evidence on treatment performance. You will own protocol development, study execution and data review, collaborating with Medical Directors and cross‑functional teams in clinical development.

You will lead protocol development, review study data for safety/efficacy trends, and shape regulatory documents.

Qualifications

• Significant experience in clinical science or clinical research within drug development.
• Experience developing clinical protocols and reviewing and interpreting clinical study data.
• Strong working understanding of ICH-GCP, clinical study design and drug development in a regulated environment.
• Ability to interpret clinical information, scientific literature and changing treatment approaches.

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.

Education

Advanced scientific or clinical degree

Job description

Hemab Therapeutics seeks an Associate Director, Clinical Sciences to translate our science into well‑designed clinical studies and robust evidence on treatment performance. You will own protocol development, study execution and data review, collaborating with Medical Directors and cross‑functional teams in clinical development.

You will lead protocol development, review study data for safety/efficacy trends, and shape regulatory documents.