Tempus AI

Tempus AI

Senior Manager, Companion Diagnostics (CDx)

Chicago · Senior

Sponsorship not specified$120k-$165kDetected 21 days ago
GCPStatisticsComplianceProject ManagementClinical TrialsPatient CareFDA RegulatoryMedical DevicesExperimental DesignCommunicationCollaborationBiostatistics

About the role

  • Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way.
  • Senior Manager, Companion Diagnostics (CDx) Tempus is seeking a Sr.
  • This is a critical, long-term resource needed to establish consistent, internal expertise for high-stakes CDx projects.

Responsibilities

  • Early Scoping & Alignment: Lead the initial scoping and planning of CDx validation projects and contracts, ensuring input from key internal experts, including Tempus Pharma sequencing, QA, CRO, and Regulatory, external IVD consultants, the drug trial sponsor, and others.
  • Protocol and Strategy Development: Lead the development of diagnostic protocols, including translating drug trial strategy into clinical Dx validation strategy, ensuring sound biostatistical approaches, and alignment on clinical data generation & analysis plans.
  • Study Execution Oversight: Take ownership of the day-to-day management and execution of regulatory-grade CDx clinical studies for major partners.
  • Project Management: Manage project deliveries, ensuring timely completion and appropriate resourcing to meet agreed-upon timelines.
  • Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
  • Manager, Companion Diagnostics to lead the planning, oversight, and execution of complex Companion Diagnostic (CDx) clinical validation studies for our pharmaceutical partners.

Requirements

  • 5 years of demonstrated experience in IVD or medical device development with a minimum of 2 years of experience in clinical study design and execution.
  • Proven ability to understand biostatistics strategy and help craft strategic workplans and Statistical Analysis Plans (SAPs) with support from SMEs (biostatistics, IVD consultants) as needed.
  • Familiarity with the distinct requirements and complexities of CDx clinical development, including clinical validation strategies and ensuring that studies are conducted and documented in accordance with good clinical practices and other applicable regulatory requirements.
  • $120,000-$165,000
  • The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
  • We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Nice to have

  • A Ph.D. or Masters in a relevant discipline is highly preferred, though equivalent professional experience will be considered.
  • Experience with GCP-grade study setup, monitoring, and reporting, including understanding of trial master file documentation and FDA strategies.
  • Ability to facilitate clear communication and coordinate resources across internal (Pharma sequencing, QA, CRO, Regulatory, others) and external (IVD consultants, the drug trial sponsor).

Compensation

  • The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York).

Benefits

  • Passionate about precision medicine and advancing the healthcare industry?

Visa & Work Authorization

  • Lead the initial scoping and planning of CDx validation projects and contracts, ensuring input from key internal experts, including Tempus Pharma sequencing, QA, CRO, and Regulatory, external IVD consultants, the drug trial sponsor, and others.
  • Work in partnership with Tempus Pharma sequencing, QA, CRO, and Regulatory, external IVD consultants, the drug trial sponsor, and others to provide necessary input and oversight for both internal and external validation work.
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