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Program Lead
Companion Diagnostic Development
Posted on 5/10/2022
INACTIVE
Locations
Chicago, IL, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Management
R
Requirements
  • 5+ years working in pharmaceutical industry and/or reference laboratory
  • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow
  • Demonstrated track record of timely completion ahead of deadlines
  • Demonstrated ability to work in a dynamic fast paced team environment
  • Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues
Responsibilities
  • Key liaison representing Tempus to pharma partners on all aspects of CDx program management from assay development to commercialization
  • Ensure internal and external milestones, deliverables, and obligations are met; manage milestone payments and activities, contractual obligations, and invoicing / payment oversight
  • Manage internal teams to execute all project deliverables; lead cross-functional internal team including R&D, bioinformatics, quality, regulatory, and operations
  • Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and FDA submission documentation meets pharma partner standards
  • Support the timely processing and reporting of our sequencing results to our partners and their collaborators
  • Take ownership of key partner-related issues and work with appropriate internal teams to resolve
Desired Qualifications
  • Master's Degree or Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field
  • 8+ years of working experience in industry
  • Experience in:
  • Assay development, including working under design controls, analytical and clinical validation plans
  • Clinical Trial Sequencing
  • Developing, implementing and supporting assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations)
  • Complying with requirements for labeling and promotion of FDA regulated diagnostic tests and drugs
  • Communicating and managing relationships with client stakeholders, ideally Pharma or Biotech
  • Communicating with regulatory bodies
  • Participating in Pharma audits
  • Understanding of HIPAA, GCP, and importance of privacy of patient data
Tempus

1,001-5,000 employees

Data-driven precision medicine
Company Overview
Tempus is on a mission to provide the necessary tools to usher in an era of precision medicine. The company has built the world's largest library of clinical and molecular data and an operating system to make that information accessible and useful for patients, physicians, and researchers.