Study Physician

Study Physician

ProQR Therapeutics

Leiden, Netherlands

Our Clinical Development team translates scientific innovation into rigorous clinical studies and development programs, with a focus on first-in-human and early-phase trials in rare diseases. You will help shape clinical-development strategy, provide medical leadership and advance RNA-editing therapies from concept to clinical evidence.

We are looking for a full-time Study Physician/Medical Director (full-time) to join our Clinical Development team. The appointment level will depend on your experience, qualifications and demonstrated scope of responsibility. This on-site role is based in Leiden, the Netherlands, and reports to the Clinical Development Lead.

Your role

In this role, you will shape early clinical-development strategy and help advance RNA-editing therapies for patients. You will combine hands-on medical oversight at study level with contributions to clinical-development strategy and work closely with colleagues across the organization to advance innovative RNA-editing therapeutics in liver and central nervous system indications.

Your responsibilities

• Lead or contribute to the design and authoring of clinical study concepts, protocols and amendments, particularly for first-in-human and early-phase trials;
• Provide medical oversight and act as medical monitor for assigned clinical studies, safeguarding participant safety, protocol compliance and data integrity;
• Review emerging clinical data, including adverse events, laboratory findings, PK/PD, biomarkers, efficacy data and protocol deviations, and support timely benefit-risk assessments;
• Contribute to clinical-development strategy for rare and orphan diseases, including patient populations, endpoints, biomarkers and development pathways;
• Serve as the medical and scientific lead and primary point of contact for the clinical study, representing the study to investigators, study sites and other external stakeholders;
• Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Clinical Pharmacology, Biostatistics and Drug Safety/Pharmacovigilance;
• Review and contribute medical content to investigator’s brochures, informed consent forms, clinical study reports, safety reports, briefing documents and regulatory submissions;
• Participate in health-authority interactions, regulatory submissions, safety-review meetings and internal governance discussions;
• Engage with investigators, study sites, CROs and external medical experts to resolve clinical questions and support high-quality study conduct.

Essential qualifications

• Medical degree from an accredited institution;
• For Study Physician level: approximately 3–5 years of relevant experience in clinical development within a CRO, biotechnology or pharmaceutical company;
• For Medical Director level: broader clinical-development experience and demonstrated leadership responsibility for clinical studies or development activities;
• Hands-on experience with the design, conduct, medical monitoring and interpretation of industry-sponsored clinical studies, preferably including first-in-human or Phase 1/2 trials;
• Sound understanding of drug development, clinical research methodology, ICH-GCP, pharmacovigilance principles and applicable regulatory requirements;
• Experience reviewing clinical and safety data and contributing to clinical, safety or regulatory documents;
• Excellent written and spoken English, with the ability to communicate complex medical and scientific topics clearly to different audiences.

Preferred qualifications

• Experience in pediatric, rare or orphan diseases;
• Experience in hepatology, metabolic disease, neurology or another relevant liver or CNS field;
• Experience with innovative therapeutic modalities, including oligonucleotides or RNA therapeutics;
• Experience in biomarker-driven early clinical development;
• Postgraduate clinical training, specialist qualification or prior patient-care experience in a relevant therapeutic area;
• Experience leading cross-functional teams or contributing to clinical-development strategy at program level.

Skills and competencies

• Sound medical judgment and a strong patient- and safety-focused mindset;
• Analytical and critical thinking, with careful attention to detail and data quality;
• A collaborative working style and the ability to influence effectively in cross-functional teams;
• Clear, concise written and verbal communication;
• A proactive, pragmatic and hands-on approach;
• The ability to prioritize multiple activities and make well-reasoned decisions in a fast-paced environment;
• Intellectual curiosity, adaptability and enthusiasm for emerging science and medicine.