Senior Manager, Precision Medicine - Clinical Diagnostics

Regeneron Pharmaceuticals Inc.; United States; Remote; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. seeks a Senior Manager, Clinical Diagnostics to drive end-to-end CDx strategy and execution across therapeutic indications.

You will translate scientific needs into fit-for-purpose assays, owning programs from feasibility through validation, registration, launch, and post-market sustainment. You will lead cross-functional teams, manage IVD partners, and contribute to global regulatory submissions (FDA, EU IVDR, PMDA).

Qualifications

• PhD in molecular biology, pathology, biomedical engineering, or equivalent.
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs.
• Proven delivery of CDx aligned to drug approvals and regulatory submissions.
• Expertise in NGS, PCR, IHC, immunoassays, and validation standards.

Responsibilities

• Execute end-to-end CDx strategy aligning milestones with clinical & regulatory timelines.
• Lead cross-functional teams, integrate workstreams, remove obstacles, and report to governance bodies.
• Manage IVD partners, negotiating scope, timelines, budgets, and quality.
• Define assay intent and contribute to target product profiles for CDx platforms.
• Embed CDx assays in trials including screening, sampling, site readiness, and lab ops.
• Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA).
• Ensure compliance with ISO 13485/14971, CLSI, IVDR, GCP; maintain documentation.

Skills

Leadership

Communication

Stakeholder management

Cross-functional collaboration

Education

PhD in molecular biology

PhD in pathology

PhD in biomedical engineering

equivalent

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics (CDx) strategy and execution across our therapeutic indications. In this role, you will translate scientific needs into fit-for-purpose assays for global decisions, owning programs from feasibility through validation, registration, launch, and post-market sustainment, while partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators.

When & where:

Location: Remote, USA

Discover your role:

• Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines
• Lead cross-functional teams, integrate workstreams, clear obstacles, and provide transparent status reporting to governance bodies and senior leadership
• Manage IVD partners, negotiating scope, timelines, budgets, and quality, and overseeing co-development and Joint Steering Committees
• Define assay intent and contribute to target product profiles for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), driving analytical and clinical validation
• Embed CDx assays in trials with clinical teams, covering screening/stratification, sampling, site readiness, and lab operations
• Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses
• Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP), maintaining documentation and audit readiness
• Thrive in a fast-paced, multi-tasking environment, bringing strong communication skills to cross-functional collaboration.

This role requires:

• PhD in molecular biology, pathology, biomedical engineering, or equivalent
• 4+ years in diagnostics development, including 2+ years leading CDx/IVD programs in pharma or diagnostics organizations
• Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions
• Expertise in NGS, PCR, IHC, and immunoassays, along with validation standards and quality systems
• Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling
• Excellent communication, leadership, and stakeholder management skills, with the ability to deliver clear updates to executive audiences

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.

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) $150,500.00 - $245,500.00

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.