The Senior Scientist II, Toxicology is in the Toxicology line function within the Preclinical Safety group. This role designs, conducts and reports GLP and non-GLP Toxicology studies in support of drug submissions to regulatory agencies.
Key Responsibilities Include:
- Act as GLP Study Director for internally conducted studies and external sponsor monitor for studies conducted at contract research organizations.
- Support submissions to global regulatory agencies for drugs in development.
- Responsible for Good Laboratory Practice compliance and AbbVie records management within assigned studies and related departmental activities.
- Design, conduct and report toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
- Demonstrate the ability to resolve study design and regulatory issues and key project hurdles and assumptions by effectively utilizing available information and technical expertise. Effective writer and communicator of research or other regulatory materials. Proactively seek relevant information in the literature and incorporate this into knowledge of Toxicology practices and overall program issues.
- Must design/critically evaluate and interpret experiments, record, tabulate and report results and significant issues. Must understand and follow established procedures and practices, ensure compliance with established procedures within the function, as well as possess a good understanding of appropriate FDA, FMLH,ICH and OECD regulations and guidelines.
- PhD in Toxicology or DVM with up to 3 years of experience in pharmaceutical toxicology, and/or Reproductive/Developmental Toxicology is required.
- The ability to recommend short-term scientific strategy and assist in long range project planning is required.
- Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; ability to work within small teams and in a matrix reporting structure environment; ability to lead scientific issue identification and resolution.
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Level and compensation will be commensurate with experience.
Point of Contact: Belen Tornesi