Lexeo Therapeutics · 1 month ago
Manager/Senior Manager, Non-Clinical Operations
New York, New York
Contract
Hybrid
Senior Level, Lead/Staff
$72/hr - $90/hr
8+ years expLexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat inherited cardiovascular diseases. The Manager/Sr. Manager, Non-Clinical Operations role involves operational oversight of outsourced non-clinical studies related to AAV-based gene therapy, including vendor management, study logistics, and regulatory document coordination.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Lead work plans (SOWs) by working with department leaders, key stakeholders and CROs following the principles of Good Laboratory Practices (GLPs/21 CFR 58), where applicable, and company Standard Operating Procedures (SOPs)
Coordinate meetings with vendors to ensure agendas are appropriate for the discussion, ensure meeting minutes are documented, follow-up on action items, and provide status updates to the internal teams
Liaise with bioanalytical leads to ensure bioanalysis is well coordinated with in-life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period
Monitor the study plan, timelines, and progress of study deliverables against forecasted timelines and budget and escalate issues that impact the study plan or budget in an effective and transparent manner
Work closely with quality assurance to ensure compliance is checked as appropriate
Summarize key findings of data as well as relevant scientific publications in presentations for internal review
Work closely with Medical Writing and contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs
Coordinate with other internal and external stakeholders, including Clinical, CMC, Regulatory Affairs, and Finance and Accounting teams
Qualification
Required
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
Company
Lexeo Therapeutics
LEXEO Therapeutics utilizes gene therapy to treat genetically defined cardiovascular and central nervous system diseases.
11-50 employees
H1B Sponsorship
Lexeo Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Balyasny Asset ManagementSarepta Therapeutics
2025-10-16Post Ipo Equity· $154M
2025-05-27Post Ipo Equity· $80M
2024-03-11Post Ipo Equity· $95M
Leadership Team
R. Nolan Townsend
Chief Executive Officer
Louis Tamayo
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase