Senior Director, Preclinical Ophthalmology

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Director, Preclinical Ophthalmology

Full Time Direct King of Prussia, PA, US

2 days ago Requisition ID: 1089

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.

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 :

• 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
• 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)