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 requires ensuring that lab environments, processes, and systems are optimized for scientific and operational excellence while maintaining regulatory compliance.

Essential Functions

• 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 such as Facilities, Biorepository, Quality Assurance, Finance, and other global site heads.
• Monitor and report site Key Performance Indicators (KPIs) including quality events, turnaround time, capacity, revenue delivery, and budget adherence.
• Ensure continuous improvement of operations and operational excellence in each laboratory.
• Responsible for weekly and monthly revenue reporting, cost tracking, and margin expansion.
• Lead and manage laboratory staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects.
• Ensure all work adheres to appropriate regulatory guidelines, CAP/CLIA/CLSI, etc.
• Work closely with Quality Assurance and regulatory teams 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 ensure timely and consistent dissemination of information to key stakeholders.
• Communicate clearly with clients and manage client expectations for all projects within the teams.
• Establish and improve company business operations processes and systems to support growth and efficiencies.
• Oversee the establishment and improvement of all procedures and required SOP documentation.
• Oversee the team in troubleshooting and correcting scientific issues/problems within the teams.
• Provide technical updates to clients as needed and serve as an escalation point for clients.
• Collaborate 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.

Qualifications

• Minimum Required:
• PhD in Immunology or related field
• 20+ years’ relevant experience
• 15+ years’ leadership experience
• Other Required:
• Prior supervisory experience
• Direct working experience and knowledge in cell-based assays/bioanalysis of large or small molecule 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
• 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 the English language
• Preferred:
• Direct experience working 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

Reasonable Estimate of the Current Range

$203,200 - $304,800 USD

Recruitment Fraud Warning

Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.