Executive Director​/Site Head

Position Summary:

The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will oversee laboratory operations across three functional groups in Frederick, Maryland. The role ensures lab environments, processes, and systems are optimized to enable scientific and operational excellence while maintaining regulatory compliance. The candidate must have deep current knowledge of FDA guidance documents and requirements and the ability to translate these requirements into practice by developing robust assays that pass FDA scrutiny.

Experience developing and managing programs following FDA/IVDR, ISO 13485 and ISO 15189 principles of design control, and understanding of CLIA and CLSI validation requirements for both cell‑based and non‑cell‑based assays is required.

• Full responsibility for operational aspects of all laboratories in Frederick, MD, including Bioanalysis, Flow Cytometry, and Companion Diagnostic.
• Support, hire, coach and mentor laboratory heads in Bioanalytical, Flow, and CDx.
• Collaborate with site supporting departments:
  Facilities, Biorepository, Quality Assurance, Finance, and other global site heads.
• Monitor and report site KPIs including quality events, turnaround time, capacity, revenue delivery, and budget adherence.
• Improve operations and enhance operational excellence in each laboratory.
• Responsible for weekly and monthly revenue reporting, cost tracking, and margin expansion.
• Provide operational excellence leadership ensuring the team is efficient and adequately resourced.
• Mentor and lead laboratory heads for all applicable laboratories.
• Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects.
• Ensure all work is completed to appropriate regulatory guidelines, CAP/CLIA/GxP, etc.
• Work closely with QA and the regulatory team to ensure compliance with industry standards.
• Attend and actively participate in FDA calls regarding assay development and compliance.
• Ensure all development and validation study protocols and reports meet CAP/CLIA and CLSI requirements.
• Establish and implement a communication strategy to disseminate information timely and consistently to engage key stakeholders across the site and within Precision.
• Communicate clearly with clients and manage client expectations for all projects within the teams.
• Establish best practices for company business operation processes and systems to support growth and efficiencies.
• Prepare and review critical documents including protocols, reports, and SOPs as applicable; oversee the establishment and improvement of all procedures and required SOP documentation.
• Oversee the team in troubleshooting and correcting all scientific issues/problems.
• Support all leaders in reviewing data and provide written and verbal technical updates to clients as needed; serve as an escalation point for clients.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise.
• Act as a scientific resource externally to clients and internally on Product and Services/R&D related projects.
• Assist with writing, reviewing, and editing contracts and scope of works, change orders.
• Maintain and support safe lab practices and environment.
• Carry out other duties/projects as assigned.

Minimum

Required:

• PhD in Immunology or a related field.
• 20+ years’ relevant experience.
• 15+ years of leadership experience.

Other

Required:

• Prior supervisory experience.
• Direct working experience and knowledge in cell‑based assays/bioanalysis of large or small molecules used for supporting clinical studies.
• A solid understanding of current GLP, GCP or GCLP standards.
• Working knowledge of CAP/CLIA, CLSI and ISO 13485.
• Experience hosting and participating in regulatory audits.
• Excellent communication, interpersonal, organizational, and multi‑tasking skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to interact and function in a highly productive work environment.
• Ability to work independently and maintain good attention to detail.
• Fluent reading, writing, speaking, and comprehension of English.

Preferred:

• Direct…