Careers

Role Summary

Lexeo is seeking an experienced and motivated clinical development leader to advance late-stage development programs as a key member of our development team. This individual will report to the Vice President, Clinical Development, Cardiology and will provide strategic and hands-on leadership across clinical strategy, study execution, and cross-functional integration to deliver high-quality evidence to support regulatory interactions and submissions (e.g., BLA). This role requires strong scientific and operational judgment and the ability to build effective partnerships with internal stakeholders and external collaborators. 

Primary Responsibilities

 
Provide clinical development leadership for assigned programs, including late-stage (Phase 2/3 and/or registrational) studies in rare disease and gene therapy.
Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing, and Clinical Operations to shape an integrated development plan aligned with program objectives and BLA strategy.
Lead clinical strategy and oversight of protocol development, endpoint selection, eligibility criteria, safety monitoring approach, and clinical rationale to support health authority interactions.
Serve as a clinical leader for investigator and external expert engagement, including KOL interactions, advisory boards (as applicable), and site relationships to support enrollment and high-quality study conduct.
Drive cross-functional issue resolution and risk management for study execution; ensure decisions are documented and aligned with quality standards and inspection readiness.
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs).
Lead and/or mentor team members through matrix leadership; support a culture of accountability, collaboration, and scientific rigor. 

Required Skills and Qualifications

PhD, PharmD, or MD with a minimum of 6 years experience in industry (8 years for Senior Director), including 5 - 6 years of progressive experience within clinical development and late-stage trial delivery.
Proven experience leading late-stage (Phase 2/3 and/or registrational) development for rare disease programs.
Demonstrated experience supporting regulatory submission readiness, including BLA filing activities (e.g., clinical deliverables coordination, inspection readiness support, and cross-functional alignment).
Thorough knowledge of development program management from IND through NDA/BLA, including audit/inspection readiness.
Experience partnering with Clinical Operations and CROs/vendors to deliver high-quality data and documentation, including milestone management, budget awareness, and reporting/CSR support.
Advanced working knowledge of relevant guidelines and regulations (including ICH, GCP, and FDA requirements).
Ability to operate effectively in a fast-paced environment with shifting priorities and timelines.
Excellent communication skills and demonstrated ability to influence across multiple functions and levels, internally and externally. 

$247,500 - $382,000 a year.

About Lexeo

Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. 

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. 

Role Summary

We are looking for a talented and highly motivated contract Lab Operations Associate Scientist/Scientist I to join the Lexeo Team in NYC to support the operations within our gene therapy laboratory. 

You will be expected to support the daily operations of the laboratory, ensuring that workflows run smoothly, safely, and efficiently. This role reports to the Lab Manager to oversee equipment, procure supplies, manage shipments, and ensure compliance with safety standards. The ideal candidate is organized, detail-oriented, and comfortable balancing administrative responsibilities with hands‑on lab support.  The nature of the role will require in-person work 5 days per week. 

Primary Responsibilities

Assist in managing day‑to‑day lab operations, including inventory management, consumables ordering, managing a stock room, and equipment maintenance
Maintain digital inventory of supplies, reagents, and equipment. Place orders and track deliveries
Oversee equipment maintenance, calibration, and service records to ensure operational readiness
Support onboarding and continuous training of laboratory staff on lab procedures and safety protocols
Monitor the environmental elements of the laboratory with safety regulations, institutional policies, and quality standards
Help develop and update standard operating procedures (SOPs) and documentation
Coordinate shipping samples, supplies, and reagents to/from a biorepository, CDMOs, and the Lexeo lab
Coordinate waste disposal, chemical storage, and safety inspections
Serve as a point of contact for vendors, facilities, and service technicians
Actively collaborate and communicate cross-functionally within Lexeo. 
The successful candidate will embrace this challenging role with enthusiasm, demonstrate the ability to work within a team, and maintain professionalism while getting things done quickly and efficiently. Attention to detail is expected. The ability to juggle many task at the same time meticulous and detail-oriented approach is crucial for maintaining accuracy.

Required Skills and Qualifications

Bachelor’s or Master's degree in a scientific discipline (e.g Biology, Chemistry,  Biotechnology)
5 years of relevant experience in lab operations (in industry or in combination with academia) with a deep understanding of lab safety
Hands-on experience in a pharmaceutical/biotech environment; knowledge of gene therapy basis a plus
Strong organizational skills with attention to detail and accuracy
Ability to manage multiple priorities and meet deadlines in a fast-paced environment
Excellent communication and coordination skills
Familiarity with Benchling or Quartzy is beneficial
Ability to regularly work onsite 5 days per week plus occasional adhoc hours outside of standard business hours when emergencies arise

About Lexeo

Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact. 

Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. 

Role Summary

The Manager/Senior Manager, CMC Quality Control (QC) is responsible for providing strategic and operational oversight of QC activities supporting Lexeo's gene therapy programs. This role serves as a QC lead for external contract testing laboratories (CTLs), analytical lifecycle management (i.e., late-phase method validation), stability programs, release testing support, and analytical investigation activities. 

The individual will work closely with Analytical Development, Technical Operations, Regulatory Affairs, Quality Assurance, and external partners to ensure analytical methods, specifications, and testing programs support clinical development, process validation readiness, and future commercial requirements. 

This position requires technical expertise in analytical testing, preferably of AAV-based products, as well as demonstrated experience overseeing external laboratories and driving cross-functional CMC initiatives. 

Primary Responsibilities

Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing activities
Support product specification lifecycle management, including establishment, justification, trending, revision, and regulatory impact assessment
Partner with Analytical Development and Technical Operations to support method qualification, validation, transfer, verification, and continued performance monitoring across testing laboratories
Serve as QC subject matter expert for laboratory investigations, including OOS, OOT, atypical results, assay failures, and method performance events
Support reference standard qualification, lifecycle management, and analytical comparability initiatives
Provide technical oversight for method transfers, comparability assessments, and laboratory readiness
Collaborate with Regulatory Affairs and CMC teams to author and review regulatory submissions, responses to health authority inquiries, technical reports, and analytical sections of INDs, BLAs, and other global filings
Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents
Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements
Collaborate with cross-functional CMC teams to align on sample submission and testing needs

Required Skills and Qualifications

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology); advanced degree (MS) a plus
6+ years of experience  or 4+ with Master’s (Sr. Manager level: BS with 8+ years or MS with 6+ years experience) in Quality Control, Analytical Development, Manufacturing Sciences, Quality Assurance, or related CMC functions within biotechnology or pharmaceutical organizations
Experience supporting late-stage development, process validation, and/or commercial readiness activities preferred
Experience supporting biologics, cell therapy, gene therapy, or other advanced therapeutics preferred
Strong understanding of cGMP regulations and global regulatory expectations applicable to analytical testing and Quality Control
Experience with analytical method lifecycle management, including qualification, validation, transfer, verification, and continued performance monitoring
Knowledge of analytical techniques commonly used for AAV and biologic products (i.e., ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, compendial safety testing)
Strong understanding of analytical control strategy development and specification management

$93,000 - $154,000 a year.

About LEXEO

Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. 

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. 

Role Summary

The Research Associate I/II will support Lexeo’s human induced pluripotent stem cell–derived cardiomyocyte (iPSC-CM) platform, a core in vitro system used to evaluate target engagement, mechanism of action, and potency across discovery and preclinical programs. This hands-on laboratory role will execute established cellular and molecular assays, contribute to assay development, and generate high-quality data. The position reports to the Head of Cardiac Research and receives day-to-day scientific direction from the Preclinical Scientist leading the platform. This is an exciting opportunity to join a cutting-edge drug discovery team advancing new therapies for patients with genetic heart disease while gaining valuable experiences for a future career in biotech and medicine 

Primary Responsibilities

Generate and validate cellular knockdown and overexpression models
Culture and maintain human iPSC-derived cardiomyocytes and other mammalian cell lines using aseptic technique
Perform ddPCR, qPCR, conventional PCR, gel electrophoresis, Western blotting, and ELISA to support mechanism-of-action and target-validation studies
Maintain complete and accurate laboratory records and contribute to the development and revision of assay SOPs
Analyze experimental data and prepare concise summaries for Preclinical team 

Required Skills and Qualifications

Bachelor’s degree in cell biology, molecular biology, pharmacology, or a related field with 1-3 years of industry and/or academic lab experience
Hands-on experience culturing iPSC and differentiation protocols for cardiomyocytes/neurons
Hands-on experience with cellular transfection methods
Experience with several of the following methods: ddPCR, qPCR, semi-quantitative PCR, Western blotting, ELISA, flow cytometry, and fluorescence microscopy
Strong laboratory skills, rigorous record-keeping, attention to detail, and the ability to work effectively in a fast-paced environment
Ability to work onsite 5 days/week at our New York City HQ  

Preferred Skills and Qualifications

Prior experience in an in vitro pharmacology group within the biotechnology or pharmaceutical industry
Experience with high-throughput screening platforms, automation and workflows
Experience with the Jess automated Western blotting platform
Experience with TR-FRET, NanoBiT, FLIPR, or MEA assays
Familiarity with engineered heart tissue models and cardiac biology
Familiarity with AI-native, agentic lab-in-the-loop workflows connecting experimental design, automated execution, real-time data analysis, and iterative decision-making
Demonstrated ability to generate, document, and communicate high-quality experimental results; publications or patents are a plus 

About LEXEO

Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. 

LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.