Senior Director, Companion Diagnostics
$203,200–$304,800 year
On-siteFrederick, Maryland, United States
Job Summary
Lead companion diagnostic teams to oversee laboratory activities for commercially approved and in-development CDx programs, ensuring scientific rigor and regulatory compliance with FDA, ISO 13485, CLIA, and CAP standards. Direct staff on assay design, validation, and troubleshooting for cell-based and non-cell-based studies while mentoring personnel in continuing education and operational excellence. Monitor quality metrics, TAT, and inventory levels to drive efficiency and streamline cross-functional deliverables. Serve as the primary scientific contact for clients, managing expectations and providing updates on project status. Participate in regulatory audits, product development, and life cycle management to maintain industry best practices.
Required Qualifications
- D. in Immunology or related field
- 8+ years' relevant experience (at least 4 years in industry)
- 5 year leadership experience
- Prior supervisory experience
- Must have 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
- Must be 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
- Must be able to read, write, speak fluently and comprehend the English language
- Deep current knowledge of FDA guidance documents and requirements, specifically relevant to companion diagnostics
- Ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny
- Experience with developing and managing programs following FDA
- ISO 13485 and 15189 principles of design control
- Understanding of both CLIA and CLSI validation requirements
- Assay execution of both cell-based and non-cell-based assays
- Direct experience in all aspects of companion diagnostics
- Large molecule regulated bioanalysis
- Working knowledge of industry best practices
- Experience with hosting and/ or participating in regulatory audits
Desired Qualifications
- Direct experience working at a CRO, Biotechnology or Pharmaceutical company
- Expertise in ELISA, MSD, Luminex, Quanterix and SPR technologies
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