Careers
- Imagine working for a company that is working to go beyond treating the symptoms of genetic disease by trying to stop its progress at its underlying cause.
- That’s what we do every day at Lexeo Therapeutics.
- We’re not content to simply make better therapies – we want to change the arc of medicine. That passion drives us, and we look for it in every person we bring to our team.
- Ready to be a part of it? See our openings below.
COMPANY BENEFITS:
Health Insurance & Wellness benefits
- Health, dental and vision benefits
- Flexible Spending Account (FSA)
- Health Savings Account (HSA)
- Disability insurance
- Life insurance
- Mental health benefits
Perks & Discounts
- Commuter benefits
- Tech stipend
- Stocked kitchen
- In office lunch stipend
Retirement & Stock option benefits
- 401(K) with company match
- Performance bonus
- Company equity
Vacation & Time off benefits
- Unlimited PTO
- Paid holidays
- Paid parental leave
Clinical Development
Director, Clinical Scientist, Gene Therapy
- Hybrid / Full time
- New York, New York, US
The Clinical Scientist is responsible for providing scientific input during protocol development, study design, oversight of clinical aspects of study conduct, and interpretation of study results through the final study report. The Clinical Scientist will work closely with other clinical development and operations team members to execute and deliver milestones. The successful candidate will be highly collaborative and motivated, with excellent knowledge of clinical trial design, preferably with experience in rare diseases and gene or cell therapy within cardiovascular disease. The candidate must also possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.
If you enjoy being a part of a growing team and an entrepreneurial environment in which your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you!
Primary Responsibilities
- Contributes to creation of clinical development strategic plan, clinical trial design, electronic case report forms (eCRFs), and statistical analysis plans
- Preparation (or oversight of vendor preparation) of protocols and ancillary study documents, case report forms, operations manuals, investigator’s brochures, and operations manuals in collaboration with Clinical Operations Director
- Preparation (or oversight of vendor preparation) of data table, listings, figures, clinical study reports and clinical submission documents
- Close collaboration with clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation
- Close collaboration with clinical operations team to review relevant vendor, CRO and site scopes of work, study budgets, and plans or manuals related to study data, IVRS, central labs, etc.
- Development of internal and external training materials and presentations
- Review and analysis of interim and final clinical trial data, including summarizing potential safety and efficacy trends, for study documents including CSRs, IBs, and DSURs
- Close collaboration with clinical development lead in strategic planning and conduct of investigator meetings and advisory boards
- Close collaboration with clinical development lead in preparation of abstracts, manuscripts, presentations, and materials for external meetings as related to the protocol and/or clinical program
- Oversight of scientific activities outsourced to vendors and clinical research organizations
Qualifications
- Relevant clinical (MD) or biomedical Ph.D. preferable
- At least 5-10 years of drug development or medical research experience within the biopharmaceutical industry; candidates with only academic experience may be considered
- Excellent knowledge of clinical trial design, statistics, and data review tools
- Significant experience in the development of protocols and case report forms
- Ability to share scientific data effectively across functions and through presentations
- Significant experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends
- Excellent knowledge of ICH and FDA GCP Guidelines
- Experience working in global regulatory and pharmacovigilance environments preferred
- Demonstrated ability to think analytically and strategically, work independently, and solve problems
- Highly motivated, accountable, self-directed, and able to execute with attention to detail
- Excellent communication and interpersonal relationship skills including negotiating and relationship management skills across multiple functions and with external vendors
- Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style
- Patient-focused with a deep commitment to understanding patient needs
- Gene therapy and/or rare disease experience in biotech company preferred
- Enjoy being part of a growing team and fast-paced environment
$176,000 - $243,000 a year
Base salary dependent on qualifications and overall experience.
About Lexeo
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March 2024 announced a PIPE raising an additional $95M, extending the Company’s runway into 2027.
Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
Apply now
Director/Senior Director, Clinical Statistician
- Hybrid / Full time
- New York, New York, US
The Director/Senior Director, Clinical Statistician will lead and manage biostatistical activities across a complex portfolio of gene therapy studies and other projects. You will collaborate with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, serving as the statistics lead on project teams, providing statistical input on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, ensuring analyses are completed appropriately and accurately, and that study results and conclusions in scientific publications/presentations and regulatory filings are scientifically sound and supported by the statistical analyses.
You will be responsible for the analysis of interim and final data sets and will oversee data and programming deliverables accountable by the CRO.
Lexeo has a hybrid work culture but is open to remote candidates within the US for this role.
Primary Responsibilities
- Responsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programs
- Ensures timely and appropriate gathering, organization, and analysis of different data sources to support clinical trial design and clinical study endpoints
- Lead statistical input to clinical trial design and protocol development
- Author statistical analysis plans in conjunction with the clinical team
- Align the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reports
- Oversees and directs completion of all technical and operational statistical activities Directs internal and external teams in the definition, execution, and completion of statistical activities for programs
- Contribute to clinical development planning for the portfolio
- Provide timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements, and identifiability of models
- Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation, ensuring accuracy of the data, that data are presented clearly, and the conclusions drawn are scientifically sound and supported by the statistical analyses
- Represent statistics function with senior management and other external partners, including regulatory agencies
- Typically takes a lead in special projects that can benefit the portfolio, such as new methodologies, processes, technology, and other tools, and may also lead the development and/or implementation of SOPs and related documentation
- Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Lexeo’s SOPs
Required Skills & Qualifications
- PhD in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment
- MS in biostatistics or related discipline with 10+ years’ relevant experience in statistical analysis of biomedical data using SAS or equivalent software
- Extensive biomedical statistical analysis experience and experience working with relevant software
- Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools typically used by Biostatistics
- Demonstrated excellence in complex project management and effectively managing multiple projects and priorities
- Experience working with CROs for data and programming deliverables
- Expert level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects
- Advanced knowledge of biostatistics best practices and tools and has shown the ability to apply this to improve overall results
- Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes
- In-depth understanding of the cross-functional roles and responsibilities involved in drug development
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and familiarity with standard clinical procedures
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees
- When needed, the ability to travel
- Ability to handle multiple development programs simultaneously
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
- Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction
- Analytical and problem-solving capabilities
- Collaborative and collegial work style
- Attention to detail and follow-up
$200,000 - $280,000 a year
Base salary dependent on qualifications and overall experience.
About Lexeo
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March 2024 announced a PIPE raising an additional $95M, extending the Company’s runway into 2027.
Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
Apply now
Senior Clinical Trial Associate
- Hybrid / Full time
- New York, New York, US
The Senior Clinical Trial Associate (SCTA) is a key position within LEXEO. Working closely with the Clinical Operations study lead (e.g. Director/Sr Director), the SCTA is responsible for supporting and overseeing the management of the day-to-day operational activities of the clinical study. The SCTA provides support to ensure successful execution of LEXEO’s clinical programs i.e. clinical trial activities and deliverables meet study and program objectives by partnering with internal and external business functions/vendors through the entire life cycle of the study (Plan/ Prepare, Initiate, Execution Close out), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Primary Responsibilities
- Support the study team with the day-to-day clinical operations of assigned study(ies) to ensure completion per established program goals and standards.
- Participate in cross-functional study teams, and liaise with other functional areas (finance, biosample management, clinical science, safety, regulatory affairs) to accurately coordinate clinical study activities.
- Manage the Trial Master File (TMF), ensuring it is complete, accurate, and inspection-ready, including performing quality control (QC) checks
- Support ongoing vendor management and oversight during the study, including review of performed work against budget, scope of work, budget amendments, performance management, and issue resolution in close collaboration with the Clinical Operations study team leader.
- Author audit and/or edit documents, relevant training materials, and presentations necessary for study initiation and execution; ensure other documents and manuals (vendor oversight, pharmacy, laboratory, audit plan, and operations manuals/plans) are sufficient and available for study initiation and execution prior to First Site Activated.
- Coordinate study Clinical Trials.gov registration and study updates, collaborating with relevant cross-functional team members such as Clinical Science and Regulatory Affairs.
- Provide input for vendor selection, requirements, and ongoing vendor management, ensuring clear communication and effective collaboration.
- Oversee agreements, CTA’s/NDA’s are fully executed and filed. Manage the site payments.
- Lead feasibility assessment and selection of countries and sites with input from Clinical Science, Clinical Operations, and other relevant cross-functional partners.
- Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data; maintain clinical study files per ICH guidance.
- Coordinate clinical study timelines with Project Management and core team to meet critical milestones; escalate issues that may jeopardize budget, timelines, and deliverables.
- Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports.
- Collaborate with study sites and vendors to ensure timely and appropriate processes for obtaining, and shipping of sample integrity for analysis and data generation.
- Oversee and resolve any corrective and preventive action plans resulting from audits or inspections, ensuring timely reporting and documentation.
- If required coordinates/provides input to Regulatory Affairs for responses to study questions or issues from Health Authorities
- Coordinates responses to study questions or issues from IRBs/IECs
- Accountable for overall TMF in the trial and conduct QC to ensure inspection readiness.
- Provide regular updates of study progression to CTM, senior clinical operations leaders, program management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Ensure compliance with ICH GCP guidelines, applicable regulations, and company SOPs.
- Perform other clinical operation activities delegated by the Clinical Operations Leader.
Required Skills & Qualifications
- BA/BS degree in life sciences or equivalent required
- Minimum of 4 – 5 years of clinical operations experience, with at least 2 years as in-house CRA within Biotech/Pharma or CRO, or at least 3 yrs as a site monitor/clinical research associate (CRA) or equivalent.
- In-depth knowledge of ICH/GCP/FDA regulations.
- Proven clinical study management skills, including experience managing timelines, budgets, and operational aspects of clinical studies. Familiarity with vendor/CRO management, drug supply planning, and operational activities.
- Proficiency in managing clinical documentation, reporting, and ensuring inspection readiness.
- Strong written and verbal communication skills demonstrated by the ability to present clear instructions/directions.
- Analytical and problem-solving capabilities with exceptional attention to detail and follow-up.
- Demonstrated ability to work collaboratively in a cross-functional team environment, maintaining a collegial and cooperative work style.
$82,000 - $137,000 a year
Base salary dependent on qualifications and overall experience.
About Lexeo
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March 2024 announced a PIPE raising an additional $95M, extending the Company’s runway into 2027.
Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
Apply now