Associate Director, Study Management
About The Position
Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry. As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most. The Associate Director, Study Management has responsibility for managing all study related activities conducted by the In Vivo Services team. The Associate Director will help to ensure that all animal-related study activities are fully supported in a timely, efficient and effective manner. They will be responsible for oversight of scheduling, coordination of work schedules, and oversight of management of the in-life phase of animal studies. The Associate Director works closely with Project Management to plan efficiently and ensure financial and resource implications are understood to better inform decision making. The Associate Director will also ensure operations are conducted in accordance with AAALAC, USDA, OLAW and GLP standards.
Requirements
- Minimum of BS/BA degree in Life Sciences, Animal Science or related field required.
- 10+ years of direct experience in the laboratory animal field.
- Knowledge of regulatory compliance and agencies (USDA, OLAW, FDA, 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.
Responsibilities
- Serve as a member of the In Vivo Services leadership team that oversees activities and functions of operational activities for animal studies performed at Franklin Biolabs
- Directly supervise two Study Managers and a Study Coordinator, ensuring alignment with study objectives, professional development, and operational excellence.
- Ensure adequate training and professional development opportunities for staff
- Develop and revise operational procedures and methods for study support
- Study implementation, scheduling, sample collection and delivery, and completion for non-GLP and GLP studies
- Review and edit study protocols
- Develop and track reviews of standard operating procedures (SOPs) to ensure compliance
- Work closely with Project Management and Finance on rate development and invoicing for all study-related activities accurately and in a timely manner
- Ensuring regulatory compliance with Franklin Biolabs’ animal care and use policies, AAALAC, USDA, and GLP
- Participation in regulatory audits and inspections as a subject matter expert (SME) as required
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
