Precision Medicine Associate II
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 . This position within Precision Medicine department requires a self-motivated individual with experience in coordinating multiple projects to support Precision Medicine Operations team. Works closely to implement and operationalize Precision Medicine goals within Regeneron's clinical trials. Manages central laboratory and specialty vendors on low to moderately complex clinical trials. The ability to perform operational tasks, troubleshoots problems, assesses and manages biomarker vendors for moderately complex clinical trials . Job Duties . Manages acquisition of clinical trial samples designated for biomarkers, precision medicine and/or exploratory research under supervision of more senior personnel . Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders . Assists Precision Medicine Scientists by assessing vendors, forecasting the biomarker sample operational costs, and reviewing invoices . Provides input on biomarker sections in clinical trial-related such as protocols and consents and other supporting documents under supervision of Precision Medicine Scientist . Prepares RFPs, reviews and assess bids and Clinical Lab Specs, Quick Reference Charts and other Central lab tools . Coordinates capabilities presentations by novel vendors . Attends conferences to identify new methodologies and technologies . Takes responsibility for coordination of events, liaisons with vendors, and communication with academic collaborators . Participates in oversight activities with vendors and supports audits as required . Provides guidance and training to clinical sites, collaborators and vendors to enable transfer of biomarker and exploratory data under supervision of more senior personnel . Supports sample and data reconciliation activities . Compliance Maintenance in Collection and Processing of Human Biospecimen . Provides guidance to clinical study teams and clinical sites regarding collection and storage of biospecimen acquired in the course of clinical trials under supervision of more senior personnel . Works with ICF Specialist and Precision Medicine Scientist to ensure compliance with ICF permissions and sample release . Requirements . JOB REQUIREMENTS . Working knowledge of the clinical drug development process . Effective problem solving skills . Excellent written and verbal communication and presentation skills in small and large group settings . Science background and working knowledge of a wide array of biological assays including proteomics, cellular assays, genomics, etc . Understanding of bioethics of human biospecimen collection and research . Ability to effectively multi-task and prioritize . Ability to work in a matrix environment . Project management/organizational skills . Interpersonal skills . Cross-functional and cross-cultural awareness . Excellent computer skills including Microsoft suite and Microsoft Access . Attention to detail is essential. EDUCATION . B. S degree . EXPERIENCE . 2-6 years pharmaceutical industry experience . SKC, #LI-SC1, ICH, GCP, project management, clinical samples, sample management, clinical operations, clinical development . 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 . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . 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.