Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases.
We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform.
Agios is leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and has demonstrated a strong commitment to these patient communities.
We continue to foster a productive research engine that yields new insights and potential therapeutic approaches.
We’re a company that cares about our work, each other, and the people who are counting on us the most.
We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results.
We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.
Agios is seeking a versatile, molecular pathologist to join our R&D team.
You will provide deep insights into pathophysiology, target discovery, and nonclinical risk assessment in the drug hunting process from early discovery through regulatory filings.
Working in a collaborative team environment with discovery and development team functional representatives, the successful candidate will contribute to the safety assessment of small molecules for genetically defined disease targets.
Critical will be the individual’s contribution to understanding disease biology and pathophysiology through the lens of toxicopathology training.
The successful candidate will design, critically evaluate and interpret results of scientific experiments and toxicology studies, including peer-review, and will contribute to appropriate sections of regulatory documents including but not limited to INDs, CTAs, and NDAs.
The successful candidate will represent the toxicology function internally and externally for nonclinical safety strategy and issue management and will also participate in internal and outsourced research collaborations.
Key Responsibilities
- Demonstrate deep understanding of molecular pathophysiology, and target-based adverse effect attribution, and employ this knowledge in guiding target selection and creation and shaping of target product profiles
- Integrate disease biology, pharmacology and toxicology findings, and effectively communicating risk assessment with Discovery and Development colleagues
- Oversee the experimental design, trouble-shooting, results interpretation, and report writing of traditional and investigative 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
- Develop discovery, investigative and regulatory toxicology strategy
- Provide representation on project teams spanning discovery and clinical development
- Influence and/or guide translational medicine approaches based on deep molecular understanding of disease pathophysiology, clinical biochemistry and hematology
- 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
Minimum Requirements
- Experience as a pathology or toxicology representative supporting Discovery and/or Development programs is required
- Experience in small molecule developmental toxicology work in both GLP, non-GLP studies and in investigative settings
- The ideal candidate will also demonstrate flexibility in the application of emerging science and technology being used to enhance pathology interpretations, understanding of disease biology, safety assessment and investigation of drug development safety issues
- Excellent written and verbal communication and team influencing skills
- The ability to work independently, as well as foster strong, highly effective cross-functional relationships both internally and externally is essential
One of the following is required:
- DVM, MD (or equivalents) and PhD (or equivalent research experience) in pathophysiology or related discipline such as immunopathology
- Board certification in veterinary pathology (DACVP/ECVP) with a minimum of 3 years of industry experience is strongly preferred but demonstrable equivalent experience or qualifications will be considered
Preferred Qualifications
- Experience in developing toxicology regulatory strategy and the preparation, writing and review of regulatory documents is preferred, but extensive experience in Discovery Toxicology will also be considered
- Experience overseeing all aspects of genetic toxicology and process impurity assessments is preferred but not required
- Expertise in a subspecialty within pathology including disease genetics, toxicology pathology, digital pathology, and immunopathology is preferred, but not required
- Expertise in ISH/FISH interpretation, genetic biomarkers, morphometry, digital pathology and machine-learning approaches as they apply to investigation of pathophysiology is preferred