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.
Requirements
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
Education and Experience requirements:
- Ph.D. in pharmacology, toxicology, or closely related biomedical disciplines with 6+ years of industry experience or M.S in above field with 10+ years of industry experience
- Diplomate of American Board of Toxicology is highly desired
- 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 is required, expertise in immunology is highly desired
- Must be able 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 are required
- Experiences working with CROs
Required Key Attributes:
- 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
- Solution and result-oriented with attention to details
Pay & Benefits:
The anticipated base salary for this position ranges from $190,000 to $220,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.
