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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in toxicology study design, monitoring, and compliance within GLP and non-GLP frameworks, while effectively leading operational activities and directing junior specialists. Proficient in data analysis and communication across drug safety and pharmacometrics domains.
Highest-signal resume keywords
Toxicology Study DesignGLP Compliance MonitoringOperational LeadershipData Analysis and ReportingPharmaceutical Drug Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Toxicology StudiesStudy MonitoringProtocol DevelopmentMetrics CollectionSOP MaintenanceStudy Design ConceptsRegulated Nonclinical Safety StudiesData InterpretationCRO CoordinationOperational Strategies
Soft Skills
Communication SkillsLeadershipCollaboration
Industry Keywords
Biological SciencesPharmaceutical IndustryDrug DevelopmentToxicologic InvestigationsNon-GLP StudiesGLP StudiesCRO MonitoringOperational GoalsMetrics ManagementSafety Studies
About the role
Key responsibilities & impact- Utilize academic training and industry experience to perform scientific, technical, and operational tasks with limited supervision
- Support the Toxicology department
- Contribute to toxicology studies and/or program development through monitoring outsourced non-GLP and GLP studies
- Conduct remote and onsite CRO monitoring
- Serve in a lead operational role for the Toxicology department
- Oversee completion of assigned department goals and activities with minimal supervision
- Direct junior specialists in support activities
- Collect and maintain metrics for Toxicology studies, including timelines and costs
- Maintain the department SOPs database
- Act as lead study monitor on GLP toxicology studies
- Contribute to study design concepts and protocols
- Coordinate logistical support for outsourced studies
- Develop protocols for outsourced toxicology studies
- Conduct study monitoring remotely or onsite at CROs to ensure compliance with approved protocols and amendments
- Review and summarize Toxicology study data and reports
- Recommend areas for further evaluation by supervisors or senior Toxicology staff
- Participate in department meetings and provide input on operational strategies
Requirements
What you’ll need- Minimum of a Bachelor's degree in biological sciences
- 6-8+ years of post-degree experience within a pharmaceutical/drug development environment
- Well-developed understanding of the theory and rationale underlying methods used in toxicologic investigations
- Significant experience in the design, monitoring and interpretation of regulated nonclinical safety studies
- Capable of communicating at all levels of drug safety and pharmacometrics
- Master's degree preferred
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required