Regeneron Pharmaceuticals, Inc

Associate Director, Clinical Diagnostics

Regeneron Pharmaceuticals, Inc • $176K — $287K *
Warren, MI 48089In-Person
Healthcare
8 - 10 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Advanced degree in a relevant field (e.g., MS/PhD in molecular biology, pathology, biomedical engineering) or equivalent experience.
  • 8+ years of experience in diagnostics development, with 4+ years leading CDx or IVD programs in pharmaceuticals or diagnostics settings.
  • Proven track record delivering CDx aligned with drug approvals.
  • Deep understanding of diagnostic platforms (NGS, PCR, IHC, Immunoassays) and associated quality systems.
  • Experience managing external IVD partners and complex, cross-functional programs.
  • Strong knowledge of global regulations (FDA CDRH, EU IVDR, PMDA).
  • Excellent communication, leadership, and stakeholder management skills.

Responsibilities

  • Set the global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
  • Lead selection and oversight of IVD partners; negotiate scopes, timelines, budgets, and quality expectations.
  • Define assay intent and target product profiles (TPP) for CDx platforms, ensuring analytical and clinical performance meets intended use.
  • Integrate CDx into trial design with biomarker and clinical teams, including sample strategy and operational readiness.
  • Drive analytical and clinical validation plans linking assay results to drug safety and efficacy.
  • Support global regulatory strategy and submissions for CDx with IVD Regulatory teams.
  • Coordinate cross-functional working groups and remove program obstacles.

Benefits

  • Health and wellness programs (medical, dental, vision, life, and disability insurance).
  • Fitness centers and wellness activities.
  • 401(k) company match.
  • Family support benefits.
  • Equity awards and annual bonuses.
  • Paid time off and paid leaves (including military and parental leave).
Full Job Description
This role provides an exciting opportunity to lead projects across diverse therapeutic areas. As the Associate Director, Clinical Diagnostics (CDx), you will own the end-to-end strategy, development, and lifecycle management of companion diagnostic solutions that enable our therapeutics. This role drives cross-functional alignment across biomarker science, clinical development, regulatory, commercial, and external IVD partners to deliver fit-for-purpose assays that meet global regulatory requirements and support clinical decision-making. You will lead the CDx portfolio from early biomarker feasibility through clinical validation, registration, launch, and post-market sustainment, ensuring timely availability of high-quality diagnostics aligned with drug development milestones.

A typical day might include:
  • Set the global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines for the therapeutic.
  • Lead selection and oversight of IVD partners; negotiate scopes, timelines, budgets, and quality expectations; manage co-development and governance.
  • Define assay intent and target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), ensuring analytical and clinical performance meets intended use.
  • Partner with biomarker and clinical teams to integrate CDx into trial designs (screening, enrichment, stratification), including sample strategy and operational readiness.
  • Drive analytical validation plans (e.g., accuracy, precision, sensitivity/specificity, LoD, reproducibility) and clinical validation strategies linking assay results to drug safety and efficacy.
  • In collaboration with IVD Regulatory, support global regulatory strategy and submissions for CDx (e.g., FDA PMA/supplement, 510(k) where applicable, EU IVDR, PMDA), including pre-submission interactions and labeling alignment.
  • Ensure compliance with applicable standards and regulations (e.g., ISO 13485, ISO 14971, CLSI guidelines, IVDR, GCP alignment for diagnostic use in trials).
  • Coordinate cross-functional working groups, remove program obstacles, and provide transparent status reporting to governance bodies.
  • Oversee design transfer, manufacturing readiness, and supply planning with IVD partners to ensure clinical and commercial availability.
  • Drive risk management and mitigation plans across technical, regulatory, operational, and commercial domains.
  • Partner with commercial and medical affairs to shape CDx launch readiness (access, coverage, distribution, training, KOL engagement).


This role might be for you if:
  • Proven track record delivering CDx aligned to drug approvals, including successful analytical/clinical validation and regulatory submissions.
  • Deep understanding of diagnostic platforms (NGS, PCR, IHC, Immunoassays) and associated validation standards and quality systems.
  • Experience managing external IVD partners and complex, cross-functional programs.
  • Strong knowledge of global regulations (FDA CDRH, EU IVDR, PMDA) and pathways for CDx approval and labeling.
  • Excellent communication, leadership, and stakeholder management skills.
  • Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.
  • Program leadership, planning, and risk management across multiple, fast-paced workstreams.


To be considered for this position, you must have:
  • Advanced degree in a relevant field (e.g., MS/PhD in molecular biology, pathology, biomedical engineering, or related) or equivalent experience.
  • 8+ years of experience in diagnostics development, with 4+ years leading CDx or IVD programs in pharmaceutical or diagnostics settings


Travel:

Travel up to 5-10% for partner meetings, clinical site visits, and regulatory interactions.

Salary Range (annually)
$176,100.00 - $287,300.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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