Precision Medicine Associate II

Location
Tarrytown, New York, US
Posted
May 05, 2018
Ref
12930BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Job Title: Precision Medicine Associate II
Department: Early Clinical Development and Clinical Experimental Sciences
Location: Tarrytown
Date: 8Jul016

SUMMARY:
Works closely with Manager, Precision Medicine and other key personnel 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. Performs other duties as necessary to ensure optimal clinical trial execution. Executes biomarker plans in collaboration with the team. Performs routine operational tasks, begins to manage, organize, and interpret clinical trial documents and vendor specifications more independently, and presents findings to his/her supervisor. Presents at investigators meetings and creates training materials (Lab Manual, Sample Collection Procedures, presentation slides, etc.). Supports senior staff on highly complex trials. The ability to perform operational tasks, troubleshoots problems, assesses and manages biomarker vendors for low to moderately complex clinical trials.
SCOPE: N/A
JOB RESPONSIBILITIES:
Study Team Support
  • Participates in cross-functional study teams and sub-teams.
  • 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.
Operational Support of Biomarker and Exploratory Analysis
  • 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 Associate Director.
Selection of Central Laboratory and Specialty Vendors
  • Prepares RFPs, reviews and assess bids and SOWs.
  • Coordinates capabilities presentations by novel vendors.
  • Attends conferences to identify new methodologies and technologies.
Central Laboratory and Specialty Vendors Management
  • 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.
Data Maintenance and Management
  • Supports information exchange and maintain data integrity.
  • 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.

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

EDUCATION
  • B.S degree – Major/ Minor (Biology, Biochemistry or equivalent)

EXPERIENCE
  • 2 - 6 years pharmaceutical industry experience.
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Requisition Number: 12930BR