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Associate Director – Toxicology
| Company | Revolution Medicines |
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| Location | San Carlos, CA, USA |
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| Salary | $164000 – $205000 |
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| Type | Full-Time |
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| Degrees | Master’s, PhD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Ph.D. degree in toxicology, pharmacology or related discipline with 5+ years, or M.S. degree with 10+ years of relevant biotech/pharma drug discovery/development experience in a team-facing roles; DABT certification is desirable.
- Experience preparing nonclinical safety sections supporting IND/NDA submissions using CTD format.
- Interactions with FDA and other regulatory agencies.
- A thorough understanding of GLP regulations as well as US and ex-US regulatory guidance documents.
- Experience with small molecules; prior experience with targeted oncology therapeutics and late-stage development highly desirable.
- Strong scientific background and scientific aptitude with excellent critical thinking skills.
- Ability to work effectively and collaboratively on cross-functional project teams; demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.
- Excellent verbal, presentation and written communication skills.
- Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment.
Responsibilities
- Function as a project toxicologist on drug discovery and development multidisciplinary teams and be a strong advocate for patient safety.
- Design and execute nonclinical toxicology strategies to advance pipeline of small molecule cancer therapeutics through all phases of research clinical development, including target de-risking, screening, issue mitigation and investigation of toxicities observed in vivo.
- Effectively implement and oversee studies outsourced to CROs, in close collaboration with study operations, pharmacology, DMPK and clinical pharmacology groups.
- Analyze, interpret, and summarize nonclinical safety data, and present contextualized findings and recommendations to internal project teams and leadership.
- Ensure timely and accurate nonclinical study deliverables of projects to enable compound progression and decision-making, including drafting and review of nonclinical sections of regulatory documents.
- Assist in the preparation of occupational toxicology documents, including occupational exposure limits (OELs), occupational health (hazard) categorizations (OHCs), and safety data sheets (SDSs), as well as product safety documents including permitted/acceptable daily exposure (PDE) assessments for products and impurities.
Preferred Qualifications
- Previous work in impurity assessment, product quality, occupational toxicology, or in silico/computational toxicology.
- Prior experience with development of oncology therapeutics.
