Senior Director, Companion Diagnostics

Position Summary

The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will oversee laboratory activities for teams supporting both commercially approved CDx sample analysis and CDx programs in development. They will lead design, development, and validation efforts for cell therapy assays to support multiple clinical and non-clinical studies for clients engaged in cutting-edge research. Key responsibilities include ensuring assays meet FDA requirements, managing regulatory compliance, and guiding assay development and troubleshooting.

Essential Functions

• Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
• Works with Lab Director to identify and provide continuing education to laboratory testing personnel.
• Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations.
• Maintain and support safe lab practices and environment.
• Prepare/review/write critical documents including protocols, reports, and SOPs.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise.
• Oversee the execution of all work to ensure the team understands and is meeting study compliance for all work performed, including study budget requirements.
• Responsible for trouble shooting and correcting all scientific issues/problems within the team.

Qualifications

• PhD in Immunology or related field
• 18+ years’ relevant experience
• 12+ years' leadership experience
• Prior supervisory experience
• Demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice
• Direct experience and knowledge in cell based assays used for supporting regulated studies
• A solid understanding of current GLP, GCP or GCLP standards
• Working knowledge of CAP/CLIA, CLSI and ISO 13485
• Excellent communication, interpersonal, organizational and multi-tasking skills
• Proficient with Microsoft Word, Excel, and PowerPoint

Reasonable Estimate of the Current Range

$203,200 - $304,800 USD

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