About This Role
This contract role for a Toxicology Scientist involves applying toxicology expertise to guide safety assessments and design in vitro/in vivo studies. The successful candidate will evaluate the safety profiles of small molecules according to regulatory guidelines, working closely with toxicology functions, CROs, and multidisciplinary drug discovery/development teams.
Responsibilities
- Represent toxicology function as a subject matter expert on drug discovery and development project teams
- Provide guidance on the safety characterization, prioritization, and advancement of drug candidates
- Directly interface with CROs to place appropriate in vitro and in vivo toxicology studies in a timely manner
- Manage and oversee the execution of toxicology studies at CROs to ensure high-quality data delivery
- Review and QC study protocols, results, and study reports
- Summarize toxicology study results and communicate toxicology findings to project teams and senior management accurately and punctually
- Contribute to the writing of safety study summaries, nonclinical overviews, and other regulatory documents
- Represent Vividion at regulatory interactions
- Identify and implement new strategies on safety assessment to address current and future safety-related challenges
- Keep abreast of current regulatory requirements by participating in cross-industry consortium or scientific conferences
- Collaborate with early discovery project teams to conduct literature-based target safety assessments
- Provide guidance on target safety derisking activities
Requirements
- Ph.D. in pharmacology, toxicology, or closely related biomedical disciplines with 3+ years of industry experience or M.S. in above field with 4-10+ years of industry experience
- A broad understanding of various aspects of nonclinical safety assessment and regulatory requirements for drug development
- Experience representing toxicology function on discovery and development teams
- Ability to critically evaluate, interpret, and integrate multidisciplinary data to support target and compound safety assessment and mechanistic derisking
- Experience in the design, conduct, and data interpretation of in vitro and in vivo safety pharmacology, genetic toxicology, and general toxicology studies
- Experience working with CROs
- Excellent interpersonal skills, with the ability to interact professionally and effectively in a dynamic, multi-disciplinary, and highly collaborative team environment
- Excellent verbal and written communication skills
- Solid problem-solving skills with a strong sense of urgency and scientific curiosity
- Proactive and agile, with the ability to operate in a fast-paced work setting
