Regeneron
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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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