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Cdx Program Manager Jobs (NOW HIRING)

Natera

Director of Alliance Management

OR · On-site +1

Program & Portfolio Oversight: Lead portfolio-level execution across patient matching, sponsored testing, CDx, and related initiatives, overseeing timelines, deliverables, and risk management across ...

Tempus

Senior Director, Research & Development

Chicago, IL · On-site

$173K - $245K/yr

... CDx, IUO, and LDT programs * Provide strategic and scientific leadership for design controls ... Strong people management experience, including hiring, mentoring, and leading teams through growth ...

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Cdx Program Manager information

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$68.5K

$118.9K

$136.5K

How much do cdx program manager jobs pay per year?

As of Sep 10, 2026, the average yearly pay for cdx program manager in the United States is $118,860.00, according to ZipRecruiter salary data. Most workers in this role earn between $116,000.00 and $116,500.00 per year, depending on experience, location, and employer.

What is a CDx program manager?

CDx Program Managers are professionals who oversee the development, regulatory approval, and commercialization of companion diagnostics (CDx) within the healthcare and pharmaceutical industries. Their role involves coordinating cross-functional teams to ensure that diagnostic tests used alongside specific therapies meet regulatory standards and are integrated into clinical practice. CDx Program Managers work closely with scientists, regulatory agencies, and commercial teams to align project timelines, budgets, and deliverables. They play a critical role in bringing personalized medicine solutions to market by ensuring that diagnostics and therapeutics are developed in tandem.

What are some common challenges faced by a CDx program manager when coordinating cross-functional teams?

As a CDx Program Manager, one of the most common challenges is aligning diverse teams—such as regulatory, clinical, R&D, and commercial—to ensure all project milestones are met within strict timelines. Navigating varying priorities and communication styles across these functions requires strong organizational and interpersonal skills. Additionally, keeping everyone informed about rapidly changing regulatory requirements for companion diagnostics adds complexity to project management. Successfully overcoming these challenges involves proactive communication, detailed planning, and fostering a collaborative work environment.

What are the key skills and qualifications needed to thrive as a CDx program manager, and why are they important?

To thrive as a CDx Program Manager, you need a strong background in life sciences or a related field, project management experience, and familiarity with companion diagnostics (CDx) and regulatory requirements. Expertise with project management tools, regulatory submission platforms, and an understanding of FDA or EMA guidelines is typically required. Exceptional leadership, cross-functional communication, and problem-solving skills help navigate complex projects and coordinate diverse teams. These competencies are crucial for successfully delivering CDx projects on time, ensuring regulatory compliance, and supporting the development of personalized medicine solutions.

What is the difference between Cdx Program Manager vs Cdx Project Coordinator?

AspectCdx Program ManagerCdx Project Coordinator
CredentialsBachelor's degree; PMP or similar certifications often preferredBachelor's degree; certifications like CAPM beneficial
Work EnvironmentOversees multiple projects, strategic planning, stakeholder communicationSupports project teams, manages schedules, assists with project tasks
Industry UsageCommon in technology, manufacturing, and logistics sectorsFrequent in similar industries, supporting project execution

The Cdx Program Manager focuses on strategic oversight and managing multiple projects, while the Cdx Project Coordinator handles day-to-day project support and coordination. Both roles require similar credentials but differ in scope and responsibilities, with the Program Manager playing a more leadership-oriented role.

Is a CDX Program Manager a stressful job?

A CDX Program Manager role can be stressful due to managing multiple projects, coordinating teams, and meeting deadlines. The job often requires strong organizational skills, problem-solving, and the ability to handle high-pressure situations, especially in fast-paced environments.

What are popular job titles related to Cdx Program Manager jobs?

For Cdx Program Manager jobs, the most frequently searched job titles are:

Infographic showing various Cdx Program Manager job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 79% Full Time, 17% Part Time, and 3% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $118,860 per year, or $57.1 per hour.

Associate Director, Precision Medicine (Clinical Diagnostics)

Tarrytown, NY • On-site

Regeneron Pharmaceuticals, Inc.
Biotechnology Research and Development • 5 - 10K employees
Learn more about Regeneron Pharmaceuticals, Inc.external

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 6 days ago

Key responsibilities

  • Lead companion diagnostic (CDx) strategy and development from early biomarker feasibility through clinical validation, regulatory submission, and launch.

  • Partner with translational, clinical, regulatory, and external IVD teams to design biomarker strategies, select assay platforms, and ensure diagnostics align with therapeutic milestones.

  • Oversee analytical and clinical validation planning, manage IVD development partners, and support regulatory submissions and compliance activities.

Regeneron rating

8.6

Company rating: 8.6 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

Job description

Build our future together:
We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch - translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions. You'll work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones.
When & where:
  • Location: Armonk, NY, Cambridge, MA, Warren, NJ
  • Work model/flexibility: 4 days onsite

Discover your role:
  • Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
  • Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
  • Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
  • Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
  • Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
  • Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
  • Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
  • Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
  • Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

This role requires:
  • PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
  • 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
  • Track record translating biomarker science into validated assays supporting drug approvals.
  • Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
  • Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
  • Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$176,100.00 - $287,300.00

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