Associate Director, In Vivo Services
On-siteKing of Prussia, Pennsylvania, United States
Job Summary
Serve as Study Director for GLP and non-GLP studies, managing end-to-end delivery of top-quality nonclinical services. Conduct observation of in-life phase procedures to ensure quality control and documentation in accordance with ALCOA principles. Draft amendments, deviations, change controls, and standard operating procedures while collaborating with the Quality Assurance Unit to maintain regulatory compliance. Act as the subject matter expert for onsite audits and inspections, addressing all auditor requests and corrections. Support project management activities to ensure timely invoicing, assist with project profitability, and provide routine updates on opportunities and risks. Requires full-time on-site presence at the Discovery Labs with up to 5% domestic and international travel.
Required Qualifications
- Minimum of Ph.D. degree in life sciences, biotechnology, pharmacology, or a related field
- 3-5 years of direct experience in nonclinical studies, including Pharm, Biotech, and/or CRO
- Knowledge of regulatory compliance and agencies (USDA, OLAW, GLP, AAALAC)
- Knowledge of animal care and use and regulatory expectations
- Strong analytical and organizational skills
- Strong interpersonal skills with the ability to influence and negotiate through conflicting situations
- Self-directed individual with the ability to perform in a fast-paced environment with limited direction, competing priorities under tight deadlines
- Ability to communicate clearly and effectively, both verbally and in writing, to interact with team members, clients, vendors and other third parties
- Ability to collaborate effectively with individuals across various disciplines to ensure alignment
- Ability to use digital communication tools (video conferencing, chat platforms etc.) to effectively collaborate with team members in hybrid and remote settings
- Ability to travel domestically and/or internationally up to 5% of the time, depending on the needs of the project, the client and the business
- Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients
- Full-time on-site presence at our Discovery Labs location
- Ability to distinguish between different colors (normal color vision)
- Ability to see clearly at various distances
- Adequate near vision for reading documents or lab equipment
- Ability to focus and maintain concentration in tasks for extended periods
- Ability to work in environments with varying light conditions
Desired Qualifications
- Experience managing studies performed under Good Laboratory Practices (21 CFR Part 58)
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