Manager, Nonclinical Operations

Apply Description Position Summary: We are looking for a highly organized and detail-oriented professional to join Nonclinical Development team. The individual is responsible for operational and administrative support within Nonclinical Development for efficient study execution and project deliverables. The role is cross-functional and involves communications among different groups within the organization and externally with CROs/vendors. Expertise in operational procedures of toxicology, ADME-PK and bioanalysis is the key to success of this position. Essential Duties and Responsibilities: Providing leadership and support as it pertains to the operation of toxicology, ADME-PK, and bioanalysis. QCs on non-clinical study (GLP or non-GLP) protocols and reports, and study record and study material management constitute a great portion of this role. Track study milestones and deliverables for internal reporting and management Serve as a primary liaison among nonclinical team, legal and finance to facilitate contract placement and execution promptly Track invoices and ensure timely payment in coordination with the finance group Support budget tracking and forecasting for all relevant studies Assist with literature research, and regulatory and submission readiness support as needed Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Requirements Preferred Education and Experience: Bachelor’s degree, or Master’s degree in biomedical areas = 6-year operational experience in pharma/biotech industry, preferably in nonclinical department or group; Expertise in Quality Control is needed Required Knowledge, Skills, Abilities & Behaviors: Strong organization and communication skills, with the ability to collaborate internally within the organization and/or externally with CROs/Vendors Great understanding and knowledge in scientific principles of toxicology, ADME-PK and/or bioanalysis Proficiency in Microsoft office software including Excel, Word, and PowerPoint