Senior Director, Preclinical Ophthalmology

Franklin Bio Lab•King of Prussia, PA

4d•Onsite

About The Position

Franklin Biolabs is seeking a Senior Director, Preclinical Ophthalmology to serve as a Study Director for GLP and non-GLP studies. This role will provide scientific leadership and management to the In Vivo Services team, ensuring the delivery of high-quality non-clinical services for clients with ophthalmic drug and gene therapy development programs. The company, emerging from Dr. Jim Wilson's laboratory, aims to redefine the genetic medicines industry by offering comprehensive services from discovery through clinical manufacturing.

Requirements

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
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)
Ability to travel domestically and/or internationally up to 5% of the time
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 required
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

Responsibilities

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