Position Description: Calico is seeking an accomplished and motivated individual to step into the role of Nonclinical Safety Leader within our Toxicology and Pathology team. This leader will collaborate with innovative and diverse scientists and play a pivotal role in advancing Calico's preclinical pipeline and development portfolio. The ideal candidate will leverage deep and proven expertise in toxicology to provide leadership for discovery and development projects, with flexibility to specialize or work across stages of development, therapy areas, and modalities.
Responsibilities: - Act as a Nonclinical Safety representative and Subject matter expert representing toxicology on project teams to support on early- and late-stage project development teams
- Proactive risk assessment of potential target pharmacology and chemotype-related toxicity issues, preparing safety strategies, and designing and implementing studies to drive toxicology plans
- Provides scientifically and strategically sound nonclinical development plans to management and development teams
- Oversee the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other toxicity studies as required
- Analyze and interpret toxicological data, ensuring accuracy and compliance with regulatory standards, and communicate toxicology findings to management and development teams
- Be accountable for authoring and review of global regulatory nonclinical documents such as CTD sections for INDs and NDAs, IBs, PIPs and health authority responses (briefing books) to support clinical trials and drug registration globally
- Contribute to global regulatory submissions (e.g., IBs, Briefing Books, INDs, NDA/BLAs) and interact with regulatory authorities worldwide on issues of nonclinical safety evaluation
- Represent Calico in external scientific and regulatory collaborations, committees and consortia
- Participate in nonclinical safety risk assessments for due diligence of potential external opportunities
- Ensure compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies, when applicable
Position Requirements: - PhD in Toxicology or related scientific discipline with 8+ years of regulatory toxicology/development experience
- Board certification (e.g. Diplomate of the American Board of Toxicology (DABT))
- Demonstrated and proven track record of successfully delivering small and large molecule candidates that have achieved preclinical candidate nomination and progressed into clinical development as the project toxicologist
- Experience in representing toxicology/nonclinical safety on multi-disciplinary project teams
- Experience in conducting or overseeing nonclinical studies with small and large molecules
- Extensive knowledge of GLP principles and FDA/ICH guidelines
- Experience in conducting due diligence of nonclinical safety data
- Self-motivated, enthusiastic, and highly adaptable with the ability to quickly identify project challenges and pivot strategies in a fast-paced environment
- Exceptional oral communication and writing skills, with record-keeping and data organization skills
- Must be willing to work onsite at least 4 days a week
Nice to Have: - Experience in developing and applying advanced in vitro models (co-culture systems, iPS-derived cells, spheroids, organoids, organ-on-a-chip) or new approach methodologies (NAMs) to address mechanistic/investigative toxicology questions
The estimated base salary range for this role is $235,000 - $315,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses
