Executive Director​/Site Head

Executive Director / Site Head of Precision for Medicine

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 focuses on optimizing lab environments, processes, and systems to enable scientific and operational excellence while maintaining regulatory compliance. A deep current knowledge of FDA guidance documents and requirements is essential, as is the ability to translate those requirements into practice by developing robust assays that easily pass FDA scrutiny.

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

• Full responsibility for operational aspects of all laboratories in Frederick (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 appropriately resourced.
• Mentor and lead laboratory head 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 the 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 ensure timely and consistent dissemination of information 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 operations, processes, and systems to support growth and efficiencies.
• Prepare and review critical documents including protocols, reports, and SOPs as applicable; oversee the creation and improvement of all procedures and required SOP documentation.
• Oversee the team in relation to troubleshooting and correcting all scientific issues/problems within the teams.
• Support all leaders in the review of data and provide written and verbal technical updates to clients as needed; be 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, scope of works, and change orders.
• Maintain and support safe lab practices and environment.
• Carry out other duties and projects as assigned.

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

• 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.
• 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.

• 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 is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential…