Sr. Precision Medicine Associate- Sample Mgmt & Clinical Ops

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary
Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. As part of this initiative, the Precision Medicine team in Early Clinical Development & Experimental Sciences (ECD&ES) is integrated with Discovery Research teams to promote early adoption of biomarker strategy to guide clinical translation and collaborates with Clinical Sciences colleagues to develop the clinical experimental sciences (CES) studies for generating clinically testable, mechanistic hypotheses for each molecule. Precision Medicine leads the biomarker strategy and execution to achieve proof of mechanism/concept in early clinical trials. The team also implements Precision Medicine strategies to support late-stage clinical programs and companion diagnostics. Our team includes Precision Medicine Strategy Leads, Precision Medicine Operations specialists, as well as quantitative analytical and companion diagnostics scientists.

Works with Precision Medicine scientists as well as clinical study teams to ensure quality samples and data are delivered to support biomarker evaluation, drug development, and delivery of science to medicine. Responsibilities include oversight of clinical sample collection, usage per informed consent, sample tracking (chain of custody) and sample destruction. Individual will work closely with internal and external groups/vendors to manage and support the generation of quality biomarker data. Will work closely with 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 amongst studies. Must possess excellent communication skills, with the ability to communicate across a matrix environment in real time. Must be able to handle a high-paced and invigorating environment, adapt quickly, drive change, be passionate about patients and science. Ability to work effectively with cross-functional teams required.

Responsibilities
Study Team Support

• Participates in cross-functional study teams and sub-teams across clinical and research sides of the company.

• Reviews and contributes to biomarker sections of clinical protocol and informed consent as needed.

• Manages acquisition of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc).

• Works closely with sample management and vendors to identify and resolve sample related issues.
Operational Support of Biomarker and Exploratory Analysis

• Assists Precision Medicine and Research Scientists by assessing, and selecting vendors, forecasting the biomarker sample operational costs, and reviewing invoices (as applicable).

• Prepares RFPs, reviews and assesses bids and SOWs with Precision Medicine Scientist and Procurement.

• Manages relationships with central laboratory and specialty 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.

• Attends conferences to identify new methodologies and technologies.
Data Acquisition and Management

• Works closely with data management lead to determine how biomarker data will be captured, blinded and transferred, including frequency of transfer.

• Enables transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and data management plan document.

• Evaluates data integrity and communicates any potential issues to Precision Medicine Scientists, Data Management and other internal/external stakeholders.

Human Sample Management Flow and Compliance

• Provides guidance to clinical teams and clinical sites regarding collection and storage of biospecimens acquired in the course of clinical trials or other human sample acquisition projects.

• Works with Precision Medicine Scientist and clinical team to ensure sample collection and usage is in compliance with ICF permissions.

• Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed per ICF permissions.
Requirements

• Working knowledge of the clinical drug development process

• Excellent written and verbal communication skills

• Ability to handle and resolve problems on the fly

• Minimum 2-3 years of experience in a fast-paced environment (lab or clinical)

• Strong project management and organizational skills

• Ability to work independently while still contributing to group initiatives and goals

• Strong interpersonal skills and ability to work with many different groups/teams to achieve success

#LI-SC1, SKC, sample management, project management, clinical operations, vendor management, precision medicine

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.