Non-clinical Study Monitor

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Irvine, CA, CA
$100,000 - $130,000
Job Type
Direct Hire
Apr 29, 2017
Job ID
Non-Clinical Study Monitor  
Global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Company is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. Offices all over the US- but this opening is for their Northern New Jersey location (commutable to NYC, on PATH line)
Global markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Company is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
At Company you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Position Description
The successful individual leads the outsourced nonclinical studies for programs in early/full development and life cycle management by serving as the study coordinator and by contributing to their design, planning, execution and interpretation. These may include nonclinical toxicology, pharmacokinetics/toxicokinetics (PK/TK), tissue materials science, and bioanalytical studies.  This individual liaises with the Project Scientists to understand the particular needs of the study selected for outsourcing and with internal sourcing partners for study placement and contracting. The individual will also liaise with the scientific counterparts of the outsourcing vendor (CRO) in order to act as Study Monitor and primary Sponsor contact for the studies.  
 Main Areas of Responsibilities
The individual, in partnership with the Project Scientists, is responsible to guide, review, and comment on the study design, compound requirements, synopsis, protocol, conduct, data and study reports to ensure that they are aligned with the expectations of both the department and that of the projects . The individual manages, in conjunction with the outsourcing vendor, the study process from protocol development to final study report, and to serve as an outsourcing expert across the organization.  The individual monitors the CRO studies including visiting the site, as needed, during the study and assures that scientific, regulatory, and animal welfare expectations are met and quality reports are delivered on agreed upon timelines.  As applicable, the individual will also work closely with cross-functional project team members to ensure all contributing reports meet project timelines.
The individual is expected to represent the department in meetings with the outsourcing vendors. The individual is responsible for creating best practices, guidance documents, and standards that make the role more effective and more uniform across study directors, CROs, and Project Scientists and to report on successes, issues, and/or needs for improvement, consistency, or best practices.  The individual will identify and lead implementation of process improvements with respect to study execution and documentation in conjunction with the Quality Assurance Unit.  Finally, the individual will be expected to support the Project Scientists in responses to regulatory agencies (FDA, EMA, etc.), as needed.
The following listed requirements need to be met at a minimum level to be considered for the job::
  • Knowledge and experience with general toxicology, pharmacokinetic, and bioanalytical principles, and general laboratory techniques 
  • Strong knowledge in GLPs and regulatory requirements for nonclinical studies and animal welfare regulations.
  • Successful in managing relationships with CROs from both a scientific and business perspective and/or experience working in a CRO with a sponsor-facing role.
  • Proven track record of coordinating multiple studies and projects to a timely completion within budget constraints with wise resource management is a must.  
  • Recognized leader working in a highly matrixed organization with strong communication, time management, and negotiating skills
  • Ability to travel at times. 
Preferred Skills/Qualifications
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
  • Experience in multiple therapeutic areas and with biologics is desirable. 
  • Experience in preparing and responding to regulatory submissions is a plus. 
PhD in toxicology or pharmacology or equivalent knowledge based upon sufficient job experience and a minimum of 2-3 years of experience gained through direct industry experience in nonclinical study conduct preferably acting as a Study Director or similar, contributing to the various aspects of nonclinical protocol design, writing, data interpretation, and/or review and reporting of results.