AbbVie

Scientist / Senior Scientist, Non-Clinical Study Monitoring

Employer
AbbVie
Location
Irvine, California
Posted
Jun 15, 2021
Ref
2106122
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Scientist / Senior Scientist, Non-Clinical Study Monitoring is responsible for monitoring non-clinical safety studies conducted at Contract Research Organizations (CROs) and for direction and execution of non-clinical studies conducted in-house in support of AbbVie’s research and development programs. These studies may include nonclinical toxicology, pharmacokinetics/toxicokinetics [PK/TK], and biological research. This role will manage the study process from protocol development to final study report.

Responsibilities:

  • In partnership with project scientists, he/she will guide, review, and comment on the study design, compound requirements, protocol, data and study reports and resolve study-related issues to ensure that studies are aligned with the expectations of both the department and that of the projects.
  • Monitor 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.
  • Work closely with cross-functional project team members to ensure all contributing reports meet project timelines.
  • Participate in key project reviews and project team meetings and interface with project nonclinical subteam representatives to understand project strategy and coordinate project and study planning.
  • Represent the department in meetings with the outsourcing vendors, including vendor qualification visits.
  • Identify best practices, and write guidance documents and standards to increase the effectiveness of the role.
  • The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, CFR and ISO guidelines as well as all AbbVie policies and procedures. AbbVie policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Qualifications
Basic:
  • M.S in toxicology, pharmacology, or a related field and a minimum of 4-6 years of related experience
  • B.S. or B.A.and a minimum of 10 years related experience.
  • Direct industry experience in non-clinical study conduct strongly preferred.
  • Ability to travel up to 30% at times.

*Job level will be commensurate with experience

Knowledge:

  • Knowledge and experience with general toxicology, pharmacokinetic, and bioanalytical principles, and general laboratory techniques.
  • Strong understanding of GLPs and regulatory requirements for non-clinical studies as well as animal welfare regulations.
  • Direct experience working with CROs from both a scientific and business perspective and/or experience working in a CRO with a Sponsor-facing role is highly desired.
  • Proven track record of coordinating multiple studies and projects to a timely completion within budget constraints.
  • Experience working in matrix organizations.  Strong communication, time management, and negotiating skills.
  • Experience working with small molecules and biologics is desirable.

Significant Work Activities
N/A
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.