Regeneron Pharmaceuticals Precision Medicine Lab Operations Study Lead in Tarrytown, New York
Working with the Precision Medicine Strategy Lead, clinical program and study teams to ensure quality biosamples and data are delivered to support clinical results, biomarker evaluation and delivery of science to medicine. Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody) and sample destruction. Work closely with internal and external groups/vendors to coordinate and support the generation of quality biomarker data. You will talk to sites, and project managers (central and/or specialty labs) to ensure samples are collected per protocol and to resolve any sample related issues or queries. Additional responsibilities include overall project/portfolio management and alignment among studies.
A typical day may include the following:
Study Team Support Activities
Participates in cross-functional study teams and sub-teams across clinical development
Works with clinical study team on the development of the ICF, including escalations from IRBs/ECs
Coordinates acquisition of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc).
Operational Support of Biomarker and Exploratory Analysis
Establishment, oversight, planning, and integration of all issues related to biosample processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations.
Liaises with Precision Medicine Strategy Leads by assessing vendors, forecasting the biomarker sample operational costs, timelines and reviewing invoices to ensure we are aligned with budget plans.
Provides input on biomarker sections in clinical trial-related (such as protocols and consents) and other supporting documents.
Prepares RFPs, reviews and assess bids and SOWs, including Lab Operation plans.
Vendor management with central laboratory and specialty laboratory vendors throughout the course of a study and is the primary point person for resolution of any issues/challenges
Evaluates emerging technologies and vendors to consider for future programs
Maintain and review metrics related to clinical study samples
Subject matter expert for biosample and lab operations, ensuring accuracy of study builds, ensuring all sample tests are accounted for during the lifecycle of the study
Data Acquisition and Management
Works closely with data management lead to determine how biomarker data will be captured, blinded and transferred for clinical trials
Enables transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and related documents
Evaluates data integrity and communicates any potential issues to Precision Medicine Strategy Leads, Data Management and other internal/external partners
Human Sample Management Flow and Compliance
Provides guidance to clinical teams and clinical sites regarding collection and storage of biospecimens.
Ensure sample collection and usage is in compliance within scope of Informed Consent Forms
Partner with the Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed per scope described in Informed Consent Forms
This may be for you if you:
• Can succeed in a high-paced and invigorating environment, adapt quickly, drive change, be passionate about patients and science and exemplify teamwork.
• Have demonstrated strong project management and organizational skills
• Can work independently and proactively while still contributing to group initiatives and goals
This position requires 8 + years of experience in related role within clinical development at a Pharmaceutical, Biotechnology company, laboratory or CRO. Working knowledge of clinical trials, clinical laboratory processes & systems, clinical databases. Comprehensive knowledge and practice using efficiency, collaboration and operations management applications and collaboration tools (e.g. Microsoft Excel, Powerpoint, Teams, Smartsheet).
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.
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