Regeneron Pharmaceuticals, Inc

Senior Manager, Clinical Diagnostics CDx (Precision Medicine)

Regeneron Pharmaceuticals, Inc • $150K — $245K *
Tarrytown, NY 10591In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
  • 4+ years in diagnostics development; 2+ years leading CDx/IVD in pharma or diagnostics organizations.
  • Proven delivery of CDx aligned to drug approvals with successful validation and regulatory submissions.
  • Expertise in NGS, PCR, IHC, immunoassays with knowledge of validation standards and quality systems.
  • Strong understanding of global FDA CDRH, EU IVDR, PMDA pathways for CDx labeling.
  • Excellent communication and stakeholder management skills with the ability to update executive audiences clearly.

Responsibilities

  • Execute end-to-end CDx strategy, ensuring alignment with therapeutic clinical development timelines.
  • Lead cross-functional teams by integrating workstreams and providing status updates to governance bodies.
  • Manage IVD partners by negotiating scope, timelines, budgets, and quality for co-development projects.
  • Define assay intent and contribute to target product profiles for CDx platforms while driving analytical validation.
  • Embed CDx assays in clinical trials, focusing on screening and sampling for reliable execution.
  • Collaborate with IVD regulatory on global submissions for FDA PMA, 510(k), EU IVDR, and PMDA.
  • Ensure compliance with regulatory frameworks and quality systems while maintaining audit readiness.

Benefits

  • Dynamic and fast-paced work environment.
  • Opportunity to lead and influence the development of cutting-edge diagnostics.
  • Collaboration with diverse teams, including clinical, regulatory, and commercial experts.
  • Engagement with key stakeholders in the field of diagnostics and therapeutics.
  • Potential for professional development in a rapidly evolving industry.
Full Job Description
As Senior Manager, Clinical Diagnostics, you will support end-to-end CDx strategy and execution to enable therapeutics across indications. Partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators, you will translate scientific needs into fit-for-purpose assays for global decisions. You will own programs from feasibility through analytical/clinical validation, registration, launch, and post-market sustainment, ensuring timelines, quality, and budgets aligned to drug milestones. This role combines hands-on leadership, vendor management, and cross-functional orchestration under quality and regulatory frameworks. You will serve as a governance interface and refine CDx strategy.

As a Senior Manager, a typical day may include:
  • Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines for seamless program delivery.
  • Lead cross-functional teams; integrate workstreams, clear obstacles, and provide transparent, regular status reporting to governance bodies and senior leadership.
  • Manage IVD partners-negotiate scope, timelines, budgets, and quality; oversee co-development, Joint Steering Committees, and performance.
  • Define assay intent and contribute to target product profiles (TPP) for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays); drive analytical validation (accuracy, precision, sensitivity, specificity, LoD, reproducibility) and clinical validation linking performance to benefit-risk.
  • Embed CDx assays in trials with clinical teams-screening/stratification, sampling, site readiness, and lab operations for reliable execution.
  • Partner with IVD Regulatory on global submissions-FDA PMA/supplements, 510(k) as applicable, EU IVDR, PMDA; support pre-subs, labeling, and responses.
  • Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management.
  • Oversee design transfer, manufacturing readiness, and supply; support launch readiness with Commercial/Medical teams.


This role may be for you if:
  • You thrive in a fast-paced environment
  • You are detail oriented, well-organized and can multi-task
  • You are a team player
  • You have strong communication skills


To be considered for this role, you must have
  • Advanced degree in molecular biology, pathology, biomedical engineering, or equivalent experience.
  • 4+ years in diagnostics development; 2+ years leading CDx/IVD in pharma or diagnostics organizations.
  • Proven delivery of CDx aligned to drug approvals; successful validation and regulatory submissions.
  • Expertise in NGS, PCR, IHC, immunoassays; validation standards and robust quality systems.
  • Strategic thinking with the ability to translate scientific and clinical needs into executable diagnostic solutions.
  • Strong grasp of global FDA CDRH, EU IVDR, PMDA pathways for CDx labeling.
  • Excellent communication, leadership, and stakeholder management; clear, concise updates to executive audiences.
  • Strategic translation of scientific and clinical needs into executable diagnostics under QMS/GxP.


Travel:

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

Salary Range (annually)
$150,500.00 - $245,500.00

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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