Clinical Trials Architect, Associate Director

Hemab Therapeutics; København; Hybrid; DKK 1,400,000 - 2,200,000; Full time

Job summary

Hemab Therapeutics seeks an Associate Director, Clinical Sciences to translate our science into robust clinical studies. You will own protocol development, study execution, and data review, collaborating with Medical Directors and a global clinical development team.

You will drive clinical strategy, ensure ICH-GCP compliance, interpret complex data, and communicate findings to internal and external stakeholders while contributing to regulatory documents and submissions.

Qualifications

• Significant experience in clinical science or clinical research within drug development.
• Experience developing clinical protocols and interpreting clinical study data.
• Strong understanding of ICH-GCP and regulated drug development processes.

Responsibilities

• Drive clinical science input into study design and execution.
• Lead protocol development with Medical Director and adapt per data.
• Review study data, identify safety/efficacy signals needing action.
• Create study documents including eCRFs, monitoring plans, and data review plans.
• Guide sites and vendors on protocol requirements and eligibility criteria.
• Collaborate with cross-functional teams to interpret results and shape development decisions.
• Contribute clinical content to regulatory documents and submissions.

Skills

Clinical research

Protocol development

ICH-GCP knowledge

Data interpretation

Cross-functional collaboration

Communication with stakeholders

Education

Advanced degree in science/medicine

Job description

Hemab Therapeutics seeks an Associate Director, Clinical Sciences to translate our science into robust clinical studies. You will own protocol development, study execution, and data review, collaborating with Medical Directors and a global clinical development team.

You will drive clinical strategy, ensure ICH-GCP compliance, interpret complex data, and communicate findings to internal and external stakeholders while contributing to regulatory documents and submissions.