The Non-Clinical Development Scientist II is responsible for being a Study Director of non-clinical studies conducted in-house and monitoring non-clinical safety studies conducted at Contract Research Organizations (CROs) in support of AbbVie’s research and development programs. These studies may include non-clinical toxicology, pharmacokinetics/toxicokinetics (PK/TK), and biological research. In partnership with project scientists, this role will guide study design, compound requirements, protocol generation, data analysis 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. The Scientist II will manage both the internal and external study process from protocol development to final study report; this includes monitoring CRO studies including site visits, as needed, during the study and assuring that scientific, regulatory, and animal welfare expectations are met and quality reports are delivered on agreed upon timelines. As applicable, this role will also work closely with cross-functional project team members to ensure all contributing reports meet project timelines and will participate in key project reviews and project team meetings and interface with non-clinical subteam representatives to understand project strategy and coordinate project and study planning.
The Scientist II is expected to represent the department in meetings with the outsourcing vendors and is also responsible for identifying best practices, writing guidance documents and standards that make the role more effective.
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.
KEY ROLES / Duties and responsibilities:
% of Time
Study Direct and serve as the primary point of control for in-house non-clinical studies required for drug development plans that are performed at the AbbVie Irvine site. Responsibilities include protocol development, coordination of study functions with IVS and RNTS staff, managing key study timelines (including updating all study timeline databases, IVS schedules and members of the study team), data analysis and reporting of study outcomes. Assist in preparation and auditing of reports and tables for regulatory submissions.
Monitor and manage outsourced non-clinical studies. Ensure quality studies that meet R&D timelines, regulatory standards (GLP, etc.) and SOPs. Facilitate review and finalization of the non-clinical protocols and reports including his/her review and ensure the completeness of these documents prior to submission to the study/project scientists. Assure that information and study correspondence is communicated in a timely manner between the CRO and study scientist and internal project team members. Collaborate with internal and external contacts to resolve study related issues as they arise while keeping the study scientist and team members informed of study status at all times. Interface with study scientists on technical data review and approval, and technical trouble shooting, if required. Assure that data and reports are delivered to AbbVie in a timely manner and meet quality expectations.
Participate in key project reviews and project team meeting activities and interface with the project team representatives to coordinate project and study planning.
Assure that CROs selected for studies meet predefined technical and regulatory requirements.
Stay abreast of technological and regulatory advancements to be able to influence the selection of CROs with technological capabilities suitable to AbbVie’s needs and in compliance with regulations. Represent the company and participate in meetings with CRO partners and in scientific meetings to acquire and share new ideas and to maintain state-of-the-art knowledge.
- M.S in toxicology or pharmacology, or in related area or equivalent knowledge and a minimum of 4- 6 years of experience gained through direct industry experience in non-clinical study conduct.
- B.S. or B.A. level education and a minimum of 10 years in a scientific discipline or equivalent experience. Ability to travel 10% or more at times.
- 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.
- 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.
- Experience working in matrix organizations. Strong communication, time management, and negotiating skills.
- Experience working with small molecules and biologics is desirable.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.