Precision for Medicine

Precision for Medicine

Senior Director, Companion Diagnostics

Frederick, MD, USA · Director

Sponsorship not specified$203k-$305kDetected 5 days ago
GCPComplianceExcelClinical TrialsFDA RegulatoryCRISPRMedical DevicesProtein AnalysisLeadershipCommunicationMicrosoft OfficeGxP

About the role

  • The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx programs in development.
  • The position requires direct experience in all aspects of companion diagnostics, large molecule regulated bioanalysis and working knowledge of industry best practices.
  • The person will work closely with QA and Regulatory to ensure regulatory compliance and work with project managers to ensure laboratory delivery and timely and efficient client communication.

Responsibilities

  • Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
  • They will use their scientific expertise to lead design, development and validation efforts for cell therapy assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research.
  • Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provides verbal or written updates as necessary.
  • Maintain and support safe lab practices and environment

Requirements

  • Minimum Required:
  • 18+ years' relevant experience
  • 12+ years' leadership experience
  • Must have demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice
  • Working knowledge of CAP/CLIA, CLSI and ISO 13485
  • 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

Compensation

  • Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
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