Senior Manager, Companion Diagnostics (CDx)

Tempus; Chicago (IL); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Incentive compensation

Restricted stock units

Medical and other benefits

Job summary

Tempus in Chicago is seeking a Senior Manager, Companion Diagnostics (CDx) to lead planning, oversight, and execution of complex CDx clinical validation studies for pharmaceutical partners. This role ensures regulatory compliance and timely study completion, bridging drug trial requirements with diagnostic validation.

You will coordinate with internal teams and external consultants, develop diagnostic protocols, draft SAPs, and manage day-to-day study activities under GCP guidelines. A Ph.D.

Qualifications

• PhD or Master’s in a relevant discipline preferred, equivalent experience considered.
• 5+ years in IVD/medical device development with at least 2 years in clinical study design and execution.
• Experience with GCP-grade study setup, monitoring, and reporting including FDA strategies.
• Ability to craft SAPs with SMEs for biostatistics and analytics.

Responsibilities

• Lead the scoping and planning of CDx validation projects and contracts with internal and external stakeholders.
• Develop diagnostic protocols translating drug trial strategy into CDx validation strategy with solid biostatistical approaches.
• Collaborate across internal teams and external consultants to oversee validation work.
• Own day-to-day management of regulatory-grade CDx clinical studies for major partners.
• Ensure all activities comply with GCP and regulatory requirements in clinical device studies.
• Manage project deliveries with appropriate resourcing and timelines.

Skills

Project management

Cross-functional leadership

Regulatory knowledge

Clinical study design

GCP familiarity

Education

PhD or Master's in a relevant discipline

Job description

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. 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. 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).

Salary

$120,000-$165,000 The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience.

Benefits

• Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Equal Opportunity Employer

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.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real-time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives. We’re looking for people who can change the world. Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.