Hybrid Associate Director – Non-Clinical Operations Lead

at Simplify

• Job title: Associate Director – Non-Clinical Operations Lead
• Job type: Full Time
• Experience level: Senior
• Salary: $125,400 - $213,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Non-Clinical Operations Lead overseeing outsourced non-clinical studies at Organon. Responsible for collaboration and operational oversight in pharmacology, DMPK, and toxicology studies.

Responsibilities

• 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