What are the responsibilities and job description for the Associate Director, Study Management position at Franklin Bio Lab?
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.
Specific responsibilities include, but are not limited to:
- 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
Education and Experience:
- 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, Skills and Abilities:
- 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.
Travel:
- Ability to travel domestically and/or internationally up to 5% of the time, depending on the needs of the project, the client and the company.
- Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients.
On-Site:
- This position requires full-time on-site presence at our Discovery Labs location.
Immunizations and Screenings:
- This position will require working with animals (e.g. Nonhuman Primates, Rabbits, Rats, Mice).
- This position requires access to lab spaces.
- This position will require access to lab animal spaces.
Essential Status:
- Essential for Research: This position may be required to go on-site to perform their regular work functions related to continued research during periods of adjusted operations. This would not likely be required to go on-site during a company closure under normal business operations.
Vision:
- 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.