Associate Director – Non-Clinical Operations Lead
Organon
full-time
Posted on:
Location Type: Office
Location: Jersey City • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $125,400 - $213,100 per year
Job Level
Senior
About the role
- Direct engagement with preclinical CROs to oversee the conduct of non-clinical studies
- Maintain collaborative CRO vendor relationship for effective conduct of non-clinical studies
- Conduct virtual and on-site qualification of new and existing non-clinical vendors
- Conduct on-site study monitoring at key study milestones
- Contribute to operational responsibilities of the non-clinical function
- Engage and communicate effectively with non-clinical team members, supporting functions within Organon, and external vendors
- Ensure the conduct of outsourced studies in accordance with Good Laboratory Practices (GLP) and relevant Organon Standard Operating Procedures (SOPs)
Requirements
- BS, MS, PhD, or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences
- Minimum of five years of experience in the pharmaceutical or biotech industry
- Extensive knowledge of operational conduct of in vitro and in vivo non-clinical studies, including toxicology, DMPK and pharmacology studies
- Demonstrated knowledge of GLP requirements
- Experience with on-site study monitoring and qualification of vendors and facilities
- Specific experience in monitoring pivotal toxicology studies
- Experience with animal handling procedures and ethical practices
- Excellent organizational and interpersonal skills
- Ability to work independently
- Ability to prioritize and focus on important details and adherence to procedures and SOPs
- Travel required (Approximately 25%)
Benefits
- Retirement savings plan
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
non-clinical studiestoxicologyDMPKpharmacologyGLPon-site study monitoringvendor qualificationanimal handling proceduresethical practicesSOPs
Soft skills
organizational skillsinterpersonal skillsindependenceattention to detailprioritization