Franklin Biolabs, Inc. is in search of a Senior Director, Preclinical Ophthalmology will serve as a Study Director for GLP and non-GLP studies, and provide scientific leadership and management to the In Vivo Services team, ensuring the delivery of top-quality non-clinical services for clients with ophthalmic drug and gene therapy development programs. Key responsibilities include, but are not limited to: - Serves as overall lead for all preclinical ophthalmology studies and programs - Serves as Study Director for GLP and non-GLP studies. - Training of in vivo services team on preclinical ocular procedures - Design, coordinate, and oversee in vivo ophthalmology studies in rodent and large animal models. - Oversee ocular dosing procedures including intravitreal, subretinal, suprachoroidal, topical, and intracameral administration techniques. - Interpret ophthalmic endpoints including slit lamp examinations, fundoscopy, OCT, ERG, fluorescein angiography, and histopathology findings. - Responsible for study reports, including final study reports, contributing scientist reports, and documentation of in-life phase, etc. - Observes in-life phase study procedures to ensure quality control (QC) and documentation in accordance with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate). - Drafts amendments, deviations, change controls, standard operating procedures (SOPs), processes, and procedures applicable to workflows. - Works with Quality Assurance (QA) to ensure compliance with all regulated aspects of a GLP lab. - Serves as the subject matter expert (SME) for all onsite audits and inspections, and the responsible party for addressing requests and corrections from the auditor team Education and Experience: - Minimum of PhD, DVM, MS, or equivalent degree in Ophthalmology, Pharmacology, Toxicology, Veterinary Sciences, or related discipline. - 8-10 years of experience in preclinical ophthalmology research ( can include academic and industry experience) - 3-5 years of direct experience as a Study Director in nonclinical studies, within Pharma, Biotech, and/or CRO. - Experience managing studies performed under Good Laboratory Practices (21 CFR Part 58). - Experience with Sponsor/client-facing communication responsibilities. Knowledge, Skills and Abilities: - Experience with small and large animal ocular studies. - Familiarity with retinal imaging platforms and ophthalmic surgical equipment. - Knowledge of regulatory expectations for ophthalmic IND-enabling studies. - Ability to interpret slit lamp examinations, fundoscopy, OCT, ERG, fluorescein angiography, and histopathology findings. - 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. - Knowledge of regulatory compliance and agencies (USDA, OLAW, GLP, AAALAC). . 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 business. - 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 in King of Prussia, Pennsylvania. Immunizations and Screenings: - This position will require working with animals (e.g. Nonhuman Primates, Rabbits, Rats, Mice). - This position requires access to lab and lab animal spaces. Essential Status: - Essential for Research: This position will be required to go on-site to perform their regular work functions related to continued research during periods of adjusted operations. Vision: - Ability to distinguish between different colors (normal color vision). - Ability to see clearly at various distances, including adequate near vision for reading documents or lab equipment. - Ability to focus and maintain concentration in tasks for extended periods, and work in environments with varying light conditions. Company Benefits: - 401(k) - 401(k) Matching - Health insurance - Dental insurance - Vision insurance - Health Savings Account and Flexible Spending Account - Paid Time-Off - Company Paid Holidays - Personal Floating Holidays - Short-Term and Long-Term Disability - Life and AD&D insurance (Group & Voluntary)