Job Title: Manager/Senior Manager, Non-Clinical Operations

Work Location: New York County, New York

Summary:

This role is responsible for overseeing non-clinical operations, ensuring studies are conducted in compliance with regulatory standards, and collaborating with internal and external stakeholders to support the development of gene therapy products.

Responsibilities:

• Develop and manage work plans by collaborating with department leaders, stakeholders, and contract research organizations, ensuring adherence to Good Laboratory Practices and Standard Operating Procedures.
• Organize and facilitate meetings with vendors, prepare agendas, document meeting minutes, track action items, and provide regular status updates to internal teams.
• Coordinate with bioanalytical leads to align bioanalysis activities with study phases and ensure proper sample tracking and storage throughout the study lifecycle.
• Monitor study plans, timelines, and deliverables, proactively identifying and escalating issues that may impact project schedules or budgets.
• Collaborate with quality assurance teams to verify compliance with relevant standards and procedures.
• Prepare and present summaries of key data findings and scientific literature for internal review and discussion.
• Work with medical writing professionals and contractors to manage the preparation and review of non-clinical study reports and regulatory documentation, including pre-INDs and INDs.
• Coordinate activities and communications with internal and external stakeholders across Clinical, CMC, Regulatory Affairs, and Finance teams.

Qualifications:

• BS with 10+ years, MS with 8+ years, or Ph.D. with 4+ years in life sciences, pharmacology, biology, physiology, biochemistry, chemistry, toxicology, or related fields, or equivalent experience.
• Minimum of 2 years of experience with AAV gene therapy products.
• Proficient understanding of GLP and ICH guidelines.
• Experience managing studies and authoring non-clinical sections of regulatory documents, especially pre-INDs and INDs.
• Strong cross-functional skills and ability to navigate complex issues and shifting priorities.
• Results-driven with strong initiative, accountability, and a proactive approach to project completion.
• Hands-on attitude, comfortable executing tasks in a dynamic, small-team environment.
• Demonstrated urgency, independence, and ability to meet tight deadlines.
• Excellent collaboration, interpersonal communication, and multi-tasking skills, with a passion for thriving in fast-paced settings.

Published Category: Discovery Research & Preclinical