Associate Director designing and improving third party management processes in Global Clinical Operations. Ensuring compliance and efficiency in clinical operations objectives.
About the role
- Direct engagement with preclinical CROs to oversee the conduct of non-clinical studies to support Organon’s pipeline projects
- 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 and coordinate with Quality Assurance as appropriate
- Conduct on-site study monitoring at key study milestones
- Contribute to operational responsibilities of the non-clinical function, including authorship of SOPs and/or policies
- Interface with Organon Procurement for vendor contracts and financial statements
- Track and coordinate non-clinical resources applied to outsourced activities/studies
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 and in-depth knowledge of the operational conduct of in vitro and in vivo non-clinical studies, including toxicology, DMPK and pharmacology studies
- Demonstrated knowledge of GLP requirements and ability to assess implementation of GLP practices
- Experience with on-site study monitoring and qualification of vendors and facilities
- Specific experience in monitoring pivotal toxicology studies is required
- Experience with animal handling procedures and ethical practices
- Exhibits effective communication and collaboration, integrity, and respectful interactions with Organon personnel
- Excellent organizational and interpersonal skills
- Ability to work independently
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
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