Support operational oversight and conduct of outsourced small and large animal non-clinical studies at contract research organizations (CROs) related to AAV-based gene therapy for cardiac disorders
Direct interactions with preclinical CROs, qualification of vendors, oversight and coordination of study logistics
Monitoring of non-clinical studies at specific milestones
Interface with Medical Writing and liaise with contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents

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 sciences or equivalent
Experience in AAV gene therapy products for minimum of 2 years
Working knowledge of GLP and ICH guidelines
Experience managing studies and authoring non-clinical sections of regulatory documents, particularly pre-INDs and INDs
Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity
Results oriented, has a bias for action. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
Accustomed to “roll up their sleeves” and execute the tasks needed in a small company environment
A demonstrated sense of urgency and ability to work independently and under tight deadlines is required
This position requires collaborative skills, strong interpersonal communication, multi-tasking ability, passion to thrive in challenges, and desire to strive in a fast-paced environment

Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.

Manager/Senior Manager, Non-Clinical Operations

Key skills