Associate Director Precision Medicine - Clinical Diagnostics

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution.

The role owns programs from feasibility through validation, regulatory submission, and launch, translating biological insights into validated assays that guide drug development decisions. You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure

Qualifications

• 8+ years in diagnostics or translational research
• 4+ years leading biomarker-driven CDx or IVD programs
• Track record translating biomarker science into validated assays
• Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA)
• Ability to translate complex scientific data for cross-functional/executive audiences
• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions

Responsibilities

• Translate biomarker and mechanism-of-action data into diagnostic target profiles across platforms
• Design biomarker strategies for patient selection, stratification and enrichment
• Lead analytical and clinical validation planning linking assay performance to clinical endpoints
• Set global CDx strategy aligning diagnostic milestones with clinical/regulatory timelines
• Select and oversee IVD development partners and manage co-development scope
• Support regulatory submissions (FDA PMA/supplement, EU IVDR, PMDA) with regulatory teams
• Ensure compliance with ISO 13485/14971/CLSI/IVDR and GCP alignment
• Lead cross-functional governance reporting and drive launch readiness preparations

Skills

Cross-functional collaboration

Regulatory knowledge

Executive communication

External partner management

Program leadership

Education

PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field

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 companion diagnostic 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: Remote, USA

Discover your role:

Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles, 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.

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.

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.

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.

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.

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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.