Temporary-Precision Medicine Operations Lead

As a Senior Precision Operations Lead, you will work on coordinating multiple projects to support the Precision Medicine Operations team. You will take the lead on implementing and operationalizing Precision Medicine goals within our clinical trials. Responsibilities will include a range of clinical trial deliverables pertaining to biomarker sample management, logistics, and data reconciliation activities. Will work closely with sites, and project managers (central and/or specialty labs). Additional responsibilities include overall project/portfolio management and alignment among studies. 

Participating in cross-functional study teams and sub-teams across clinical development
Working with clinical study team on the development of the ICF, including escalations from IRBs/ECs
Working closely with sample management and vendors to identify and resolve sample related issues
Establishing, 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. 
Providing input on biomarker sections in clinical trial-related (such as protocols and consents) and other supporting documents.
Preparing RFPs, reviews and assess bids and SOWs, including Lab Operation plans.
Maintaining relationships with central laboratory and specialty laboratory vendors throughout a study and is the primary point person for resolution of any issues/challenges
Maintaining 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
Collaborating with data management lead to determine how biomarker data will be captured, blinded and transferred for clinical trials
Enabling transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and related documents
Evaluating data integrity and communicates any potential issues. 
Providing 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
Ensure sample collection and usage is in compliance within scope of Informed Consent Forms 
Works closely with internal 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: 
•    Are interested in the management of immune-oncology clinical trials and research.
•    Have working knowledge of trials, clinical laboratory processes & systems, clinical databases
•    Ability to handle and resolve problems on the fly
•    Strong project management and organizational skills
•    Ability to work independently and proactively while still contributing to group initiatives and goals
•    Strong interpersonal skills and ability to work with many different groups/teams to achieve success
•    Ability to effectively multi-task and prioritize

To be considered for this your are required to have a Bachelors degree in a life scient along with 4+ years of proven experience in related role within clinical development at a Pharmaceutical, Biotechnology company, laboratory or CRO. 
•    Must possess excellent communication skills, with the ability to communicate across a matrix environment in real time. 
•    Demonstrated experience to handle a high-paced and invigorating environment, adapt quickly, inspire change, be passionate about patients and science and exemplify teamwork. 

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.