Senior Principal Scientist, Preclinical Safety

Employer
AbbVie
Location
Worcester, MA, US
Posted
May 07, 2019
Ref
1902368
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Preclinical Safety group works globally with AbbVie's discovery and translational research teams to guide in the generation of the hypotheses, mechanism-of-action, safety and efficacy data on projects that fuel the AbbVie pipeline. We also work with our clinical and regulatory teams to generate the toxicology and biodistribution data that is critical to translating each of AbbVie's innovative therapies safely from research into patients.

We are seeking a project team member to join the Preclinical Safety group team at the Immunology R&D site in the Worcester, MA location. He/she will collaborate with business partners to contribute to the selection and characterization of new chemical and biologic entities from Immunology research and support advancement of promising entities into the clinic. The qualified candidate will represent the PCS discipline on discovery and development project teams and suggest and implement strategies and tactics to advance high-quality therapeutics as part of the overall program(s).

Key Responsibilities:

  • Responsible for nonclinical program strategies and the design, implementation and as needed, reporting of preclinical in vitro and in vivo safety studies to support molecule progression into clinical development programs
  • Guide implementation of good documentation practices in a rapidly expanding organization with an emphasis on supporting operational excellence to the In Vitro Immunosafety (IVIS) group
  • Collaborate with Research in the screening and selection of final IND candidates and novel assay development
  • Assess new targets and products for mechanism(s) of toxicity to determine clinical relevance and ways to minimize clinical impact and/or effectively position AbbVie projects
  • Create the Preclinical Strategy and oversee study execution per project timelines
  • Represent preclinical safety at Project Team level and attend other meetings related to research pipeline and progression to target validation, candidate nomination and clinical development
  • Work cross-functionally across the organization to ensure effective execution on nonclinical program deliverables, including with Research, CMC, Regulatory, and Clinical functions
  • Support scientific strategy to guide the design of novel translational biomarker assays and lab-developed tests required for new programs, ensuring appropriate application in nonclinical studies
  • Attends all core team meetings and serves as a single point of contact for communication between the project team and preclinical operations.
  • Assess, communicate and manage the risks associated to the preclinical evaluation of product concept for projects to ensure success.
  • Surveys the literature to identify and compare competitive product performance and safety risks.


Position will be hired based on level of experience.
  • PhD in a relevant discipline, DVM or MD Degree
  • Proven knowledge of drug discovery and development process with a minimum of 8-10+ years of experience in a drug discovery environment, preferably industry
  • The ability to lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, and risk; flexibility is required
  • Excellent written and oral communication skills is a must