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TRIUM Clinical Consulting NV

Lead consultative sales discussions with senior stakeholders and decision-makers * Identify and win new clients across Europe, focusing on mid-size and large Medical Device and IVD companies. You ...

BSI Prof Serv EHS West

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Group

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Group

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Group

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Prof Serv EHS West

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Prof Serv EHS West

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Prof Serv EHS West

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

BSI Group

Job Title- Technical Specialist- IVD (In Vitro Diagnostic) Location: EMEA/UK- Homebased BSI is ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

Visa Hunt

$127K - $168K/yr

The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing ...

Precision for Medicine

Director, CDx Regulatory Consultant

$153K - $202K/yr

The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing ...

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Senior Manager, Companion Diagnostics (CDx)

Chicago, IL • On-site

Tempus
See more jobs at Tempusexternal

$120K - $165K/yr

Full-time

Re-posted 11 days ago

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).

$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.

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