Project and Regulatory Toxicologist
Vividion Therapeutics, Inc
Summary
The Project and Regulatory Toxicologist will be expected to use his/her toxicology expertise to guide safety assessment, design and interpret in vitro/in vivo studies to evaluate the safety profiles of our covalently and non-covalently targeted small molecules according to regulatory guidelines. You will work closely with the toxicology function, CROs, and multidisciplinary drug discovery/development teams to progress promising therapeutics to the clinic.
Job description
Job Summary
The Project and Regulatory Toxicologist will be expected to use his/her toxicology expertise to guide safety assessment, design and interpret in vitro/in vivo studies to evaluate the safety profiles of our covalently and non-covalently targeted small molecules according to regulatory guidelines. You will work closely with the toxicology function, CROs, and multidisciplinary drug discovery/development teams to progress promising therapeutics to the clinic.
Essential Duties and Responsibilities
- Represent toxicology function as a subject matter expert on drug discovery and development project teams and 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 summary, nonclinical overview and other regulatory documents, represent Vividion at regulatory interactions
- May need to 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 and provide guidance on target safety derisking activities
Requirements
- Ph.D. in pharmacology, toxicology, or closely related biomedical disciplines with 4+ years of industry experience, or M.S. in above field with 10+ years of industry experience
- Diplomate of American Board of Toxicology highly desired
- Broad understanding of nonclinical safety assessment and regulatory requirements for drug development
- Experience representing toxicology function on discovery and development teams
- Expertise in immunology highly desired
- Ability to critically evaluate, interpret and integrate multidisciplinary data to support target and compound safety assessment and mechanistic derisking
- Experience in 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
- Excellent verbal and written communication skills
- Solid problem-solving skills with strong sense of urgency and scientific curiosity
- Proactive and agile in a fast-paced work setting
- Solution and result-oriented with attention to details
Benefits
- Target Bonus
- Long-Term Incentives
- 401(k) Matching
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
Company overview
Vividion Therapeutics, Inc. is a biotechnology company focused on transforming the future of human health through the creation of highly selective small molecule medicines that drug traditionally inaccessible targets. Founded in 2017 and based in San Diego, California, the company leverages a cutting-edge covalent-first chemoproteomics platform spun out of The Scripps Research Institute. Vividion's innovative approach enables the discovery of novel therapeutics that bind challenging disease-causing protein targets previously considered 'undruggable'. The company is advancing a diversified pipeline of selective small molecule therapeutics targeting key proteins in oncology and immunology, with multiple clinical-stage programs including VVD-037 (a KEAP1 activator) and VVD-642 (a RAS-PI3Kα inhibitor) for non-small cell lung cancer and other RAS-driven cancers. With 201-500 employees, Vividion combines deep expertise in chemical biology and synthetic chemistry to develop first and best-in-class medicines for patients with devastating diseases.