Reporting to the Vice President, Translational Research the position will be responsible for the design and conduct of nonclinical safety assessment programs to support the progression of novel therapeutic agents through the drug development process. A strong background in regulatory toxicology including extensive knowledge and understanding of Good Laboratory Practices is required.
- Design and oversee the conduct, interpretation, and reporting of regulatory toxicity studies
- Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery scientists, and affiliated nonclinical and clinical development functions as necessary
- Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners
- Responsible for lead authorship of pertinent sections of internal and external regulatory documents (IBs, CTXs, INDs, NDAs, Expert Reports, etc.)
- Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
- Communicate unambiguous critical and significant project information to various bodies including project teams and Angion leadership as required
- Collaborate on the design of investigative toxicity studies in support of development compounds as needed
- Ph.D. in Toxicology or relevant field; DABT Board certification desired
- 10 plus years of experience in the Pharmaceutical Industry with a proven track record of conducting drug safety assessment studies, demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments
- Proficient knowledge of general toxicology is required
- In-depth understanding and working knowledge of regulatory toxicology and US and international regulatory guidelines
- Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
- Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization