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 clinical and non-clinical studies, leveraging deep knowledge of FDA guidance and requirements.

Essential Functions

• Mentor and lead all companion diagnostic teams to ensure high quality, compliant data.
• Work 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.
• Monitor and provide metrics, KPIs to senior leadership, including quality metrics, TAT, assay failure rate, volumes, and revenue.
• Monitor inventory (client and Precision inventory) and lab supplies; ensure staff perform regular inventory counts and update the inventory software system.
• Ensure lab operations are efficient, review processes, SOPs, and implement improvements regarding operational excellence.
• Be the main point of contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provide verbal or written updates as necessary.
• Participate actively in the companion diagnostics community to stay informed about relevant guidance in the Cell & Gene Therapy Industry.
• Participate in product (device) development, commercialization, and lifecycle management.
• Have good working knowledge of ISO 13485 Design Control procedures, ISO 15189 Medical Laboratories, CLIA, and CLSI requirements for assay validation.
• Coordinate cross-functional activities between Precision business units and among various subject matter experts to enhance operational efficiencies and streamline deliverables to clients.
• Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements.
• Oversee the execution of all work to ensure the team understands and meets study compliance for all work performed, including study budget requirements.
• Responsible for troubleshooting and correcting all scientific issues/problems within the team.
• Prepare/review/write critical documents including protocols, reports, and SOPs.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise.
• Maintain and support safe lab practices and environment.
• Carry out other duties/projects as assigned.

Qualifications

• Minimum Required:
• PhD in Immunology or related field
• 18+ years’ relevant experience
• 12+ years' leadership experience
• Other Required:
• 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
• Ability to interact and function in a highly productive work environment
• Ability to work independently and have good attention to detail
• Fluency in reading, writing, speaking English
• Preferred:
• Direct experience working at a CRO, Biotechnology, or Pharmaceutical company
• Expertise in ELISA, MSD, Luminex, Quanterix, and SPR technologies

Reasonable Estimate of the Current Range

$203,200 - $304,800 USD

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