Principal Investigator (PI) — Clinical Research (Cologne, Germany)
Role Overview
We are seeking a Principal Investigator (PI) with a medical background to lead and oversee clinical research projects in Cologne. The PI will be a licensed medical doctor (Approbation in Germany required), responsible for the conception, execution, and supervision of clinical trials or translational research.
The role combines clinical expertise with scientific leadership, ensuring that projects meet the highest standards of patient safety, ethical compliance, and scientific excellence.
Key Responsibilities
* Clinical & Research Leadership
* Serve as the lead physician for assigned clinical studies.
* Define research objectives and methodologies, integrating clinical knowledge with scientific innovation.
* Ensure patient-centered care and ethical conduct throughout all trial phases.
* Regulatory & Ethical Oversight
* Obtain and maintain all necessary regulatory and ethics approvals.
* Guarantee adherence to German medical law (AMG, MPG), GCP guidelines, and institutional policies.
* Act as the medically responsible investigator (ärztlicher Leiter) for clinical studies.
* Patient Safety & Medical Oversight
* Ensure participant safety, oversee informed consent, and manage adverse event reporting.
* Provide direct medical oversight during study conduct.
* Team & Project Management
* Supervise research staff including sub-investigators, study nurses, and coordinators.
* Mentor junior physician-scientists and researchers.
* Collaborate with sponsors, CROs, and institutional partners.
* Funding & Grant Management
* Secure external funding (e.g., DFG, EU Horizon Europe, BMBF).
* Manage project budgets and resources effectively.
* Data Integrity & Dissemination
* Oversee collection, validation, and analysis of clinical data.
* Publish results in high-impact journals and present at international conferences.
Qualifications & Requirements
* Education & Credentials
* Completed medical degree with full German approbation (license to practice medicine).
* Specialist training (Facharzt) preferred, particularly in internal medicine, oncology, neurology, or relevant field.
* Experience
* Demonstrated track record in clinical or translational research.
* Prior experience as sub-investigator or PI in clinical trials strongly preferred.
* Evidence of publications and successful grant applications.
* Skills
* Strong knowledge of clinical trial design, GCP, and medical regulations in Germany/EU.
* Excellent leadership, mentorship, and communication abilities.
* Fluency in German (C1+) and English required.