Senior Director, Safety and Toxicology
The Senior Director of Safety and Toxicology will be a seasoned Toxicologist able to lead the Safety and Toxicology function for Selecta Biosciences. Reporting directly to the Chief Medical Officer, the successful candidate will be expected to manage toxicology and safety pharmacology studies for compounds in various stages of research and development occurring simultaneously across the strategic business areas, Gene Therapy, Enzyme Therapy, and Autoimmune Diseases. The candidate will possess proven collaboration skills, having served in Toxicology leadership roles in cross functional teams, interacting with Discovery, Clinical, and CNC teams on a regular basis. In partnership with Clinical Research Organizations (CROs), the successful candidate will be responsible for planning, conducting, and interpreting all non-clinical toxicology studies.
Developing safety and toxicology strategies for NCES
Design toxicology trials, identify and work with CROs to schedule the studies, continually monitor studies, and interpret the toxicology study results.
Aid in the preparation of regulatory submissions and maintain regulatory submissions (annual reports, IBs, INDs, and CTAs).
Aid in the preparation of responses to inquiries from regulatory agencies.
Perform due diligence on external consultants and Clinical Research Organization (CROs) including visiting CRO sites to review facilities and capabilities, ensuring timely conduct and delivery of reports, and negotiating budgets.
Effectively communicate toxicology study related information to management, CROs, and external parties.
Experience working with nanoparticles preferred
Energy to work on a variety of programs, demonstrates true excitement for the work itself
An in-depth understanding of all aspects of toxicology with the ability to work in a team-based environment to ensure effective translation from discovery through to clinical studies
Track record of robust experimental design, execution, and interpretation of data
Strong reasoning ability in the identification of problems and the ability to draw conclusions and make responsible decisions.
The ability to utilize and/or develop connections within the scientific community and utilize these resources in the resolution of issues.