Temp Senior Precision Medicine Associate

As a Senior Precision Medicine Associate you will work with our Precision Medicine Strategy Leads and clinical study teams to ensure quality samples and data are delivered to support biomarker evaluation and delivery of science to medicine. You will be responsible for the oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody) and sample destruction. You will collaborate with our internal and groups and external vendors to coordinate 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.

A typical day may include:
• Participating in cross-functional study teams and sub-teams across clinical and research teams.
• Collaborating with clinical study team on the development of the ICF, including escalations from IRBs/ECs
• Managing the acquisition of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc).
• 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.
• Maintaining relationships 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.
• Evaluating new 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
• Works closely with data management lead to contributing to 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.

This may be for you if:
• Can multi-task with effective project management/organization skills.
• Thrive in a high-paced and invigorating environment.
• Are process driven with attention to detail
• Can work independently to achieve group initiatives and goals
• Have excellent interpersonal skills to translate clinical needs to many different internal and external teams

To be considered for this you need to have a Bachelors degree with a major or minor in Biology or equivalent. Your experience should include 6 - 8 years of clinical research experience with academic, CRO or pharmaceutical/biotech industry. Solid understanding of clinical trials and clinical databases is essential. Strong project management and organizational skills are required. The ability to handle and resolve problems on the fly.

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.