Scientific Director, Preclinical Safety

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 Scientific Director to join the Preclinical Safety team in Worcester, MA. 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 and assay standards to support operational excellence to the In Vitro Immunosafety (IVIS) group
• Assess new targets for mechanism(s) of toxicity to support clinical development and develop a preclinical strategy for project progression
• 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.
• 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.

Position will be hired based on level of experience.

• PhD in Science or related field with typically 8-10+ years of related work experience; Master's Degree or equivalent education Science or PharmD or equivalent education with extensive (typically 14-16+ years) of related work; Bachelor's Degree or equivalent education in Science related field with extensive (typically 16-18+ years) of related work.
• Minimum of 10+ years in an industry drug discovery is preferred
• A strong understanding of the drug discovery and development process
• Experience with design, implementation and interpretation of Non-GLP and/or GLP preclinical safety studies
• Experience with in vitro assays; Immunotoxicology is a plus
• The ability to lead, build trust, communicate and work effectively in a team-oriented environment; flexibility is required
• Excellent written and oral communication skills are a must