Associate Director - Non - clinical Operations Lead

Non-Clinical Operations Lead

The Non-Clinical Operations Lead within the Non-Clinical Development Team (NCD), is responsible for operational oversight conduct outsourced non-clinical studies at contract research organizations (CROs), including toxicology, DMPK and pharmacology studies. The NCD team is comprised of drug development scientists representing toxicology, DMPK, and pharmacology, serving a key function within the Translational Medicine and Early Development (TMED) team. Non-Clinical Operations Lead will report to the Non-Clinical Safety Assessment Lead and work collaboratively with other members within the NCD team including safety assessment (toxicology) and translational sciences. The Non-Clinical Operations Lead will work closely with non-clinical project team representatives and non-clinical management to ensure the operational aspects of outsourced contract studies are conducted with the upmost quality and compliance. Key functions of the position include direct interactions with preclinical CROs, on-site qualification of vendors, oversight and coordination of study logistics (e.g., contracts, test articles, study records, etc.), and on-site monitoring of non-clinical studies at specific milestones. Additionally, this position will interface with Quality Assurance (QA) and their representatives, contribute to the authorship of non-clinical standard operating procedures (SOPs) and policies, and serve as a liaison between non-clinical development and Organon procurement. Knowledge of the operational conduct of the various stages of in vitro and in vivo safety studies is required and a deep understanding of GLP practices is essential.

Responsibilities

• Direct engagement with preclinical CROs to oversee the conduct of non-clinical studies to support Organon's pipeline projects, including non-clinical pharmacology, DMPK, and toxicology 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 and coordinate with Quality Assurance as appropriate. (travel required, as necessary).
• Conduct on-site study monitoring at key study milestones (e.g., first dose, necropsy, etc.).
• Contribute to operational responsibilities of the non-clinical function, including authorship of SOPs and/or policies, interfacing with Organon Procurement for vendor contracts and financial statements.
• Track and coordinate non-clinical resources applied to outsourced activities/studies in conjunction with department management.
• 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).

Required Education, Experience and Skills

• 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 with 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.
• Ability to prioritize and focus on important details and adherence to procedures and SOPs.
• Travel required (Approximately 25%).