Allergan Non-Clinical Study Monitor in Irvine, California
Non-Clinical Study Monitor
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/808/other-jobs-matching/location-only
Dec 17, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan 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, Allergan 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.
Join one of the world’s fastest growing specialty pharmaceutical companies!
At Allergan 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 stretch assignments and opportunities to step into the spotlight.
The successful individual leads the outsourced nonclinical studies for programs in early/full development and life cycle management by serving as the study monitor and by contributing to their design, planning, execution and interpretation. These may include toxicology, pharmacokinetics/toxicokinetics (PK/TK), and medical devices 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, 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 serves as an outsourcing expert across the organization. The individual monitors the CRO studies including site visits, 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 identifying best practices, writing guidance documents and standards that make the role more effective.
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 of GLPs and regulatory requirements for nonclinical studies and animal welfare regulations.
Experience working 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.
Experience working in matrix organizations. Strong communication, time management, and negotiating skills.
Ability to travel up to 30 - 60% at times
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
- Experience working with small molecules and biologics is desirable
M.S in toxicology or pharmacology, or equivalent knowledge based upon sufficient job experience, and a minimum of 4- 6 years of experience gained through direct industry experience in nonclinical study conduct.