Senior Manager, Companion Diagnostics (CDx)Tempus is seeking a Sr. Manager, Companion Diagnostics to lead the planning, oversight, and execution of complex Companion Diagnostic (CDx) clinical validation studies for our pharmaceutical partners. This is a critical, long-term resource needed to establish consistent, internal expertise for high-stakes CDx projects. This role will bridge the gap between drug trial requirements and diagnostic validation, ensuring regulatory compliance and timely study completion.
Key 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.
- Cross-Functional Collaboration: 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.
- Study Execution Oversight: Take ownership of the day-to-day management and execution of regulatory-grade CDx clinical studies for major partners.
- Regulatory & Quality Compliance: Ensure all clinical validation activities meet the requirements for running clinical device studies, including adherence to GCP and regulatory scrutiny.
- Project Management: Manage project deliveries, ensuring timely completion and appropriate resourcing to meet agreed-upon timelines.
Qualifications- A Ph.D. or Masters in a relevant discipline is highly preferred, though equivalent professional experience will be considered.
- 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.
- Experience with GCP-grade study setup, monitoring, and reporting, including understanding of trial master file documentation and FDA strategies.
- 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.
- Ability to facilitate clear communication and coordinate resources across internal (Pharma sequencing, QA, CRO, Regulatory, others) and external (IVD consultants, the drug trial sponsor).
$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.
