Associate Director, Precision Medicine (Clinical Diagnostics)

Initial Therapeutics, Inc.; Armonk (NY); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron seeks an Associate Director to lead companion diagnostic strategy, translating translational science into validated CDx assays that inform drug development decisions. You’ll oversee biomarker programs from feasibility through clinical validation and launch, coordinating with translational, regulatory, and external IVD partners.

You will drive global CDx strategy, manage partner co-development, ensure regulatory alignment, and translate complex data for executive audiences while

Qualifications

• 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.
• Experience translating biomarker science into validated assays for drug approvals.
• Experience with global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
• Ability to translate complex scientific data for cross-functional and executive audiences.
• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Responsibilities

• Translate emerging biomarker and mechanism data into diagnostic target product profiles across platforms.
• Design biomarker strategies for patient selection, stratification, and enrichment including sample strategy.
• Lead analytical and clinical validation planning and link assay performance to clinical endpoints.
• Set global CDx strategy aligning diagnostic milestones with regulatory timelines.
• Oversee IVD development partners; manage co-development scope, timelines, and quality expectations.
• Support regulatory submissions (FDA PMA/supplement, EU IVDR, PMDA) with labeling alignment.
• Ensure compliance with ISO 13485/14971, CLSI, IVDR and GCP alignment.
• Lead cross-functional governance reporting and drive design transfer and manufacturing readiness.
• Support launch preparation with commercial and medical affairs.

Skills

CDx strategy

Biomarker development

Cross-functional leadership

External partner management

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 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? 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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