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(senior) medical director clinical development

München
ARTO
Medical Director
Inserat online seit: 17 Februar
Beschreibung

ARTO are partnered with a well funded biotech in Munich who, with clinical programs heading towards phases II and III, are looking to grow their clinical development team with another experienced Physician.

The ideal candidate will be based in Germany, with the ability to travel to the office in Munich on a regular basis when required.

About the Job

* Lead medical strategy and execution for assigned clinical trials, primarily a Phase 2b HCC study, ensuring high-quality design, startup, conduct, monitoring, and data interpretation.
* Serve as Medical Lead driving cross-functional collaboration across Clinical Operations, Regulatory, Safety/PV, Biostatistics, Data Management, QA, and Translational Oncology.
* Oversee ongoing medical monitoring, including patient-level safety and efficacy review, protocol deviation assessment, and safety signal detection.
* Provide medical leadership in regulatory and ethics interactions, including Health Authority responses and submission documentation.
* Prepare and review key clinical documents (protocols, IB, DSUR, safety plans) and contribute to publications, investigator meetings, and scientific communications.
* Ensure compliance with ICH-GCP, SOPs, and inspection readiness standards; may mentor or line-manage Clinical Scientists depending on experience.

Qualifications

* Medical Doctor, Board Certification preffered but not required.
* 5+ years in clinical/drug development (8+ years for Senior level), with oncology clinical development experience; Immuno-Oncology preferred.
* Hands-on experience in Phase I/II trials, including early development decision-making and dose-escalation governance.
* Demonstrated expertise in medical monitoring, IDMC processes, and cross-functional clinical trial leadership.
* Strong knowledge of ICH-GCP, clinical trial methodology, EDC workflows, and translational/biomarker endpoint interpretation.
* Solid tumor experience required

Please reach out via DM or through email (jamie.stephens@arto-talent.com) if you are interested!

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