Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios is seeking a toxicologist or toxicologic pathologist to join our toxicology team and provide nonclinical safety expertise in the drug development process from discovery through late stage development. Working in a collaborative team environment with discovery and development team functional representatives, the incumbent will contribute to the safety assessment of small molecules for oncology and rare genetic disease indications. The successful candidate will design, critically evaluate and interpret results of scientific experiments, and contribute to appropriate sections of regulatory documents including but not limited to INDs, CTAs, and NDAs. The incumbent will represent the toxicology function internally and externally for nonclinical safety strategy and issue management, and participate in internal and outsourced collaborations.
The successful candidate will:
Oversee experimental design, trouble-shooting, results interpretation, and report writing of nonclinical safety studies
Collaborate and communicate effectively with CROs from initial study design to reporting of preliminary results and interpretation and QC of the final report.
Have a strong understanding of how preclinical science functions come together to support toxicology needs
Develop investigative and regulatory toxicology strategy
Provide expertise in genetic toxicology and handling of process impurities
Represent toxicology on project teams spanning discovery and clinical development
Understand the needs of and strongly influence partners in discovery and development functions for the success of the programs
Identify and communicate potential project hurdles, as well as suggest solutions, establish priorities and contingency plans in collaboration with line function management, key partners in research, clinical and project team participants
Education: One of the following is required:
Master’s Degree in Toxicology or a related science with a minimum of 6 years of industry toxicology experience (DABT preferred)
PhD in Toxicology or a related science with DABT certification and a minimum of 3 years of industry experience
Board certification in veterinary pathology (DACVP/ECVP) with a minimum of 3 years of industry experience
Experience as a toxicology representative supporting safety assessment on Discovery and/or Development programs is required
Experience in developing toxicology regulatory strategy and the preparation, writing and review of regulatory documents is required
Required expertise in small molecule developmental toxicology work in both GLP and non-GLP studies
Experience overseeing all aspects of genetic toxicology and process impurity assessments is preferred but not required
Expertise in a subspecialty within the toxicology field is preferred, but not required
The ideal candidate will also have an understanding of emerging science and technology being used to enhance safety assessment and investigation of drug development safety issues
Excellent written and verbal communication skills
The ability to work independently, as well as foster strong, highly effective cross-functional relationships both internally and externally is essential