Precision Medicine Group
Executive Director of Companion Diagnostics / Site Head
Frederick, MD, USA · Director
Sponsorship not specified$228k-$341kDetected 34 days ago
ExcelProcess ImprovementFDA RegulatoryCRISPRFlow CytometryMedical DevicesLeadershipGxP
About the role
- The position requires deep expertise in companion diagnostics within the Cell and Gene Therapy space, including a strong working knowledge of FDA guidance and global regulatory frameworks.
- Essential functions of the job include but are not limited to:
- Provide full operational oversight of all laboratory functions in Frederick, MD, including Bioanalysis, Flow Cytometry, and Companion Diagnostics
Responsibilities
- Drive operational excellence through efficient resource allocation, capacity planning, and process optimization
- Partner with cross-functional teams including Facilities, Biorepository, Quality Assurance, Site Leadership, and Finance
- Lead, hire, coach, and develop high-performing teams, including laboratory heads and scientific staff
- Lead and support regulatory interactions, including FDA meetings and audits
Requirements
- Minimum Required:
- 20 years of relevant experience, including at least 4 years in industry and including 12 years as a functional manager
- Deep expertise in Companion Diagnostics, particularly within Cell and Gene Therapy
- Strong knowledge of FDA guidance and global regulatory frameworks (IVDR, ISO 13485/15189, CLIA, CLSI, CAP, GxP)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Expertise across multiple assay platforms, including:
Compensation
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
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