About the Role
A clinical-stage oncology-based company is seeking an experienced Medical Director, Global Clinical Development to lead late-stage clinical programs. The role has a strong focus on diagnostic imaging and theranostic development, combining strategic leadership with hands-on execution in a highly matrixed biotech environment.
This is a high-impact position with direct ownership of pivotal trials, regulatory interactions, and benefit–risk strategy.
Key Responsibilities
* Lead overall medical and clinical strategy for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
* Provide medical leadership for diagnostic and therapeutic radiopharmaceutical clinical trials
* Act as primary author and senior reviewer of clinical protocols, IND clinical sections, SAP-relevant content, and Clinical Study Reports (CSRs)
* Oversee benefit–risk assessments and clinical interpretation of imaging and diagnostic performance data
* Lead and support FDA and EMA interactions, including scientific advice and briefing documentation
* Collaborate closely with regulatory affairs, clinical operations, biostatistics, translational research, and external partners
* Contribute to development strategy, endpoint selection, and go/no-go decisions
* Operate effectively in a small, agile, resource-lean organization, balancing strategic leadership with operational detail
Required Experience & Qualifications
* Background in Radio/Nuclear Medicine or diagnostic imaging strongly preferred
* Significant experience in diagnostic imaging, ideally including PET/CT and molecular imaging
* Proven hands-on leadership of late-stage oncology or diagnostic development programs
* Strong understanding of registrational clinical trial design and regulatory expectations
* Demonstrated experience leading FDA and EMA interactions
* Ability to combine strategic oversight with hands-on execution
* Fluent in English; German language skills are a plus
Why Consider This Opportunity?
* Ownership of pivotal clinical development programs
* Exposure to innovative theranostic and imaging-based approaches
* High visibility role with meaningful influence on clinical and regulatory strategy
* Opportunity to work in a science-driven, collaborative biotech environment
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