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

Essential Functions

• Full responsibility of operational aspects for all laboratories in Frederick MD; including Bioanalysis, Flow Cytometry and Companion Diagnostic.
• Support, hire, coach and mentor laboratory lab heads in Bioanalytical, Flow and CDx.
• Collaborate with site supporting departments: Facilities, Biorepository, Quality Assurance, Finance, as well as other global site heads.
• Monitor and report site KPIs including quality events, turnaround time, capacity, revenue delivery and budget adherence.
• Is fully responsible for improving operations and enhancing operational excellence in each laboratory.
• Responsible for weekly and monthly revenue reporting, cost tracking and margin expansion.
• Provide operational excellence leadership ensuring that the team is efficient and has appropriate resourcing.
• 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 our regulatory team to ensure compliance to industry standards.
• Attend and actively participate in FDA calls regarding assay development and compliance.
• Ensures 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.
• Is responsible for establishing best practices for company business operations processes and systems to support growth and efficiencies.
• Prepare/review critical documents including protocols, reports, and SOPs as applicable: Oversee the establishing and improving of all procedures and required SOP documentation.
• Oversee the team in relation to trouble shooting 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.
• Aid in 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
• 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
• 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

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EEO Statement

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.

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