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: Bioanalysis, Flow Cytometry, and Companion Diagnostic. The role ensures that laboratory environments, processes, and systems are optimized to achieve scientific and operational excellence while maintaining regulatory compliance. Knowledge of FDA guidance documents, ISO 13485, 15189, CLIA, CLSI, and GCLP is required.

Essential Functions

• Full responsibility for operational aspects for all laboratories in Frederick, MD.
• Support, hire, coach, and mentor laboratory heads in Bioanalysis, Flow Cytometry, 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.
• Ensure all work complies with regulatory guidelines (CAP/CLIA/GxP).
• Work closely with QA and regulatory teams to maintain compliance with industry standards.
• Attend and actively participate in FDA calls regarding assay development and compliance.
• Ensure that development and validation study protocols and reports meet CAP/CLIA and CLSI requirements.
• Establish and implement a communication strategy to disseminate information to stakeholders.
• Communicate clearly with clients and manage client expectations for all projects.
• Establish best practices for company business operations, processes, and systems.
• Prepare and review critical documents, including protocols, reports, and SOPs, and oversee SOP documentation.
• Oversee troubleshooting and resolution of all scientific issues within the teams.
• Support leaders in reviewing data and providing technical updates to clients; act as an escalation point for clients.
• Collaborate with other technical teams on resource sharing and technical expertise.
• Act as a scientific resource externally to clients and internally on product and R&D related projects.
• Assist with writing, reviewing, and editing contracts, scope of works, and change orders.
• Maintain and support safe lab practices and environment.
• Carry out other duties and projects as assigned.

Qualifications

Minimum Required:

• PhD in Immunology or a related field.
• 20+ years of 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.
• Solid understanding of 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 function in a highly productive work environment.
• Ability to work independently with strong attention to detail.
• Fluency in English (reading, writing, speaking).

Preferred:

• Direct experience at a CRO, biotechnology, or pharmaceutical company.
• Expertise across multiple technology platforms, including ECL, ligand-binding assays (LBA), cell-based plate assays, flow cytometry, and enzymatic activity assays.

Benefits

• Salary range: $203,200 – $304,800 USD (competitive with geographic differential).
• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation, among other benefits.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.