Job Description
The Biomarker Assay Quality group within Precision Medicine is a newly established function with a remit to supervise novel assay development, fit-for-purpose method validation, and data QC and review across multiple platforms (flow cytometry, histochemistry, genetics, transcriptomics, ELISA, etc) from external laboratories supporting Regeneron clinical trials. We are seeking to hire a Precision Medicine Assay Quality Lead (PMQL) role at the associate director level with expertise in clinical genotyping and NGS-based molecular testing to complement existing strengths. In this highly matrixed role, this individual will independently ensure that externally led assay development and method validation plans are robust. The individual will prepare method validation summaries describing assay performance prior to clinical implementation. The individual will also conduct pilot studies to define/identify pre-analytical variables impacting assay performance prior to and during clinical trials as needed.
As an Associate Director, a typical day may include the following:
Independent oversight of assay development and validation across multiple technical platforms with a focus on clinical genetic testing, pharmacogenetics and molecular analysis (DNA, RNA, NGS)
Work on a core team to build, implement and harmonize processes and tools to manage the quality of clinical assays including clarifying and capturing the intended use of biomarkers in clinical studies and identifying compliant biomarker assay testing solutions
Work with vendors to standardize and harmonize processes for biomarker sample matrix selection, specimen collection, processing and storage with a focus on minimizing pre-analytical variable impact on clinical endpoints
Work in close collaboration with biomarker scientists, clinical scientists, medical directors, and regulatory leads to review intended use and assay requirements in clinical trials to ensure compliance with regulatory guidances including EU IVDR and US CAP/CLIA regulations
Collaborate with Global Clinical Operations to build strong partnership with Central and Specialty labs and provide monitoring and oversight for laboratory execution at the external vendors.
Improve efficiency for biomarker assay development and validation within precision medicine, Regeneron external laboratory vendors/partners, diagnostic vendors/partners as well as cross-functionally across Regeneron
Collaborate with internal Regeneron laboratories (e.g. Discovery Research, Molecular Profiling, Regeneron Genetics Center, DNA core, BioAnalysis, etc.) to apply and validate research assays and generate standardized assay method document
Contribute to Precision Medicine technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management; review documents pertaining to regulatory interactions and filings related to Precision Medicine deliverables
This role may be for you if:
You have the ability to drive, manage, execute and deliver results for complex multi-functional projects
You have excellent communication and presentation skills and high emotional intelligence, organizational skills and effective team skills
To be considered for this role, you must have a PhD and 10 years’ experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry. We are seeking at least 3 years in clinical assay development, validation and implementation, with a track record of high impact in drug development.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)