Job Category:Preclinical Development
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
• Develop and oversee non-clinical safety and toxicology drug development plans for small molecule CNS compounds with estimated costs, timing, and risk assessment/management
• Identify and resolve nonclinical study operational issues and maintain project timelines
• Develop safety-related issue mitigation or resolution plans and coordinate execution of the experimental plan as required
• Interact with CRO’s to coordinate, design and monitor GLP and non-GLP toxicology and safety pharmacology studies
• Critically review and edit CRO toxicology study reports, analyze and interpret data (e.g., toxicology, DMPK, analytical) and coordinate report finalization
• Coordinate cross-departmental activities necessary for the effective conduct of safety assessment studies
• Advise discovery project teams on target-based toxicological risks and develop monitoring and testing strategies
• Communicate toxicology study findings, including relevance and interpretation, to project teams
• Prepare and edit non-clinical documents for regulatory submission (e.g. INDs, IB’s, and regulatory briefing documents)
• May interact with regulatory agencies on nonclinical matters
• Maintains a current understanding of toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
• Maintains a current understanding of regulatory requirements and guidances
• PhD in toxicology, pharmacology or related field
• DABT certification desirable but not required
• 10 years of experience managing and working in industrial pharmaceutical toxicology/safety assessment drug development
• Experience with small molecules required
• Experience in CNS research is an advantage
• Good understanding of analytical/bioanalytical measurement techniques and methodology
• Ability to synthesize and interpret diverse, multidisciplinary data sets
• Experience participating on drug development teams and IND submissions
• Experience in designing, monitoring and interpreting non-clinical safety studies
• Excellent communication, multitasking, and collaboration skills
• Thorough knowledge with FDA and ICH guidance documents including GLP regulations
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.