Executive Director of Companion Diagnostics / Site Head

Position SummaryThe Executive Director, Companion Diagnostics (CDx) / Site Head is a senior leadership role responsible for overseeing laboratory operations across multiple functional areas in Frederick, Maryland, including Bioanalytical, Flow Cytometry, and Companion Diagnostics. This role leads CDx programs from early development through commercialization while ensuring scientific excellence, operational efficiency, and full regulatory compliance.The position requires deep expertise in companion diagnostics within the Cell and Gene Therapy space, including a strong working knowledge of FDA guidance and global regulatory frameworks. The Executive Director will play a critical role in building scalable laboratory operations, advancing assay development, and positioning the organization as a leader in CDx innovation.Essential functions of the job include but are not limited to: Site & Operational LeadershipProvide full operational oversight of all laboratory functions in Frederick, MD, including Bioanalysis, Flow Cytometry, and Companion DiagnosticsEstablish and monitor key performance indicators (KPIs) such as quality, turnaround time, capacity, revenue delivery, and budget adherenceDrive operational excellence through efficient resource allocation, capacity planning, and process optimizationPartner with cross-functional teams including Facilities, Biorepository, Quality Assurance, Site Leadership, and FinanceLeadership & Talent DevelopmentLead, hire, coach, and develop high-performing teams, including laboratory heads and scientific staffFoster a culture of accountability, collaboration, and continuous improvementMentor scientists and technical staff to ensure high-quality, compliant data generationScientific & Technical LeadershipProvide strategic and technical oversight for development and validation of cell-based and non-cell-based assaysEnsure scientific rigor, reproducibility, and alignment with industry best practicesServe as a subject matter expert in CDx assay development, including bioanalytical and flow cytometry platformsTroubleshoot complex scientific issues and guide teams toward effective solutionsRegulatory & Quality ComplianceEnsure compliance with all applicable regulatory standards, including FDA, IVDR, ISO 13485, ISO 15189, CLIA, CLSI, CAP, and GxP requirementsLead and support regulatory interactions, including FDA meetings and auditsReview and approve protocols, validation reports, and technical documentationPartner closely with Quality Assurance and Regulatory Affairs to maintain audit readinessProgram & Product Lifecycle ManagementLead CDx programs from concept through development, validation, commercialization, and lifecycle managementEnsure adherence to design control principles and regulatory expectations throughout the product lifecycleCoordinate cross-functional activities to streamline deliverables and enhance operational efficiencyClient & External EngagementServe as a senior scientific and operational representative to clientsManage client relationships, expectations, and escalationsProvide technical updates and strategic guidance to internal and external stakeholdersRepresent the organization within the broader companion diagnostics and Cell & Gene Therapy communityBusiness Development SupportContribute to proposal development, grant applications, and client presentationsProvide technical input into business development opportunities and strategic initiativesQualificationsMinimum Required:D. in Immunology or a related scientific field20 years of relevant experience, including at least 4 years in industry and including 12 years as a functional managerDemonstrated leadership experience managing multi-functional laboratory teamsDeep expertise in Companion Diagnostics, particularly within Cell and Gene TherapyStrong knowledge of FDA guidance and global regulatory frameworks (IVDR, ISO 13485/15189, CLIA, CLSI, CAP, GxP)Proven experience developing and validating assays to support clinical studiesExperience participating in regulatory audits and agency interactionsExcellent leadership, communication, and stakeholder management skillsProficiency in Microsoft Office (Word, Excel, PowerPoint)PreferredExperience within a CRO, biotechnology, or pharmaceutical organizationExpertise across multiple assay platforms, including:Ligand-binding assays (LBA)Electrochemiluminescence (ECL)Flow cytometryCell-based plate assaysEnzymatic activity assaysPrecision 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 associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range: $227,600 USD - $341,400 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.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.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.