Nonclinical Safety and Pathobiology Lead at Gilead Sciences
Overview
We seek a seasoned Nonclinical Safety professional to lead outsourced GLP and non-GLP studies from planning through final report. The ideal candidate combines scientific expertise with operational ownership to deliver inspection-ready outputs. This role drives quality assurance, manages CRO collaborations, and ensures regulatory compliance across discovery and IND-enabling programs. You will shape study timelines, resolve complex issues, and mentor junior staff while championing inclusion and talent development.
What You'll Do10
- 1Independently monitor and coordinate outsourced nonclinical safety studies supporting discovery IND-enabling and regulatory development programs
- 2Lead study monitoring for multi-study projects developing timelines and identifying critical path activities
- 3Review protocols amendments raw data summaries draft reports and regulatory documents for scientific accuracy and compliance
- 4Coordinate report review cycles prepare study result slides compile study summaries and assist project toxicologists with regulatory submissions
- 5Perform independent QC review of protocols reports SEND outputs and regulatory documents to ensure inspection readiness
- 6Apply expertise in GLP-regulated nonclinical studies toxicology study conduct animal welfare expectations and regulatory guidance to mitigate risks
- 7Participate in CRO site selection technical qualification visits vendor oversight and monitoring visits escalate issues as needed
- 8Support departmental initiatives SOP review process improvement vendor oversight enhancements onboarding mentoring colleagues serve as technical resource for study designs CRO interactions and monitoring best practices
- 9Conduct literature searches apply findings to study planning interpretation and regulatory support activities
- 10Travel for CRO monitoring or qualification activities typically less than fifteen percent of time
Requirements9
- 1Bachelor's Degree with six years experience or Master's Degree with four years experience
- 2Direct experience independently monitoring GLP-regulated nonclinical safety studies across multiple study types species therapeutic areas and modalities
- 3Strong understanding of toxicology principles animal and human biology physiology study design dose selection toxicokinetics pathology workflows and nonclinical development requirements
- 4Working knowledge of Good Laboratory Practice regulations FDA ICH EMA OECD and other relevant guidelines
- 5Familiarity with laboratory animal welfare standards USDA AAALAC and IACUC review processes
- 6Proven ability to manage CRO relationships coordinate concurrent studies anticipate risks resolve conduct or reporting issues and maintain timelines under tight deadlines
- 7Excellent written and verbal communication skills to convey complex study information to scientific operational quality and regulatory stakeholders
- 8Advanced proficiency with Microsoft Word PowerPoint Excel and study tracking systems document management SEND dataset tools and electronic QC workflows
- 9Membership or active participation in professional organizations such as ACT or SOT encouraged
Salary Insight
$147 - $190k per year
Location
Required Skills
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