Executive Director/Site Head

Precisionmedicinegroup; Frederick (MD); On-site; USD 203,200 - 304,800; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement benefits

Life insurance

Paid time off

Job summary

Precision Medicine Group seeks an Executive Director / Site Head of Precision for Medicine, onsite in Frederick, MD, to oversee three laboratory groups, optimize processes, and ensure regulatory compliance. You will translate FDA guidance into robust, passing assays, shaping GLP/GCP/GCLP programs and QC systems across Bioanalysis, Flow Cytometry, and CDx.

The role requires deep regulatory knowledge, 20+ years in the field, and 15+ years in leadership, with strong interpersonal skills to mentor

Qualifications

• PhD in Immunology or a related field required.
• 20+ years of relevant experience; 15+ years in leadership.
• Strong knowledge of GLP/GCP/GCLP standards and regulatory audits.

Responsibilities

• Oversee operations of Bioanalysis, Flow Cytometry, and CDx labs in Frederick, MD.
• Hire, coach, and mentor laboratory heads; drive operational excellence.
• Ensure regulatory compliance with CAP/CLIA and CLSI; manage budgets and KPIs.
• Communicate with clients and stakeholders; provide technical updates and escalation support.

Skills

Leadership experience

Regulatory knowledge

English proficiency

Cell-based assays knowledge

Education

PhD in Immunology or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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.

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: 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.

Qualifications

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 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.

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.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. The disclosed range estimate has not been adjusted for applicable geographic differentials. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role; compensation decisions are dependent on the facts and circumstances of each case. This role is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

$203,200 – $304,800 USD

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