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 - $193,000 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 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 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
Regulatory
Sr. Manager, Regulatory Operations
- Hybrid / Full time
- New York, New York, US
The Sr. Manager, Regulatory Operations, plays a pivotal role in ensuring the seamless coordination of regulatory submission activities after document content is finalized. Working within a dynamic regulatory team, this individual will be responsible for managing the end-to-end process of document-level publishing, submission assembly, compliance review, and document management/archive, as well as overseeing the maintenance and enhancement of systems critical to regulatory operations. A Veeva Systems expert, the Sr. Manager will lead the implementation, optimization, and continued support of Veeva systems for regulatory document management and compliance tracking. The Sr. Manager will work collaboratively with the Regulatory Affairs and Medical Writing team along with project teams and other functional areas to ensure high-quality submission content.
Lexeo has a hybrid work culture but is open to remote candidates within the US for this role.
Primary Responsibilities
- Oversee the organization, review, and maintenance of documents for regulatory submissions, ensuring accuracy, consistency, and adherence to regulatory requirementsand compliance with local and regional registration requirements as well as with company policies.
- Implement and maintain archiving strategies to support long-term record-keeping and regulatory compliance, including organizing and categorizing records within Veeva.
- Compile regulatory documents into compliant submissions, ensuring all materials are formatted correctly and meet FDA, EMA, and other relevant agency standards.
- Publishes electronic submissions in Electronic Common Technical Document (eCTD) for FDA. This may include source document formatting, internal and external hyperlinking,bookmarks and sequence-level publishing.
- Manage document readiness and finalization, coordinating with internal stakeholders to assemble, review, and finalize submissions in alignment with project timelines.
- Support literature management and assembly as part of submission preparation.
- Establish and manage submission tracking processes, ensuring that submission statuses are accurately maintained and communicated to relevant stakeholders.
- Develop and implement tracking dashboards or reporting tools to provide real-time updates on submission progress and maintain visibility for project teams.
- Develop and administer in-house training, as needed, to ensure optimal use of templates, processes, and tools critical to compiling submissions
- Organize, track, and maintain submission components associated with regulatory submissions. This may include, but not exclusive to, setting up templates, printing, and maintaining records/data in the Regulatory Information Management (RIM) system.
- Coordinate and track delivery of required content with content owners for routine/maintenance submissions
- Provide advice on acceptability of regulatory submission plans, from a Regulatory Operation perspective
- Provide support in software validation/migration/updates specific to systems in Regulatory Affairs. Support the implementation, maintenance, and continuous improvement of authoring and publishing systems and processes striving for publishing excellence.
- Act as the System Administrator (superuser) for Veeva RIM within Regulatory Operations, driving system implementation, customization, SOP development, and continuous improvement. Specifically:
- Creates, uploads, and versions documents in the Veeva RIM vault.
- Create and manage binders using Veeva RIM.
- Uploads submissions to the submission archive in Veeva RIM.
- Provide ongoing training, troubleshooting, and support for Veeva users within regulatory and cross-functional teams to ensure system alignment with business needs.
- Collaborate with publishing vendors to manage submission timelines, ensure quality standards, and address submission requirements promptly.
- Maintain vendor relationships, serving as the regulatory operations point of contact and ensuring vendors meet company and regulatory expectations for submission quality.
- Monitors global health authority regulations, guidelines, and specifications relevant to publishing and submissions including FDA, EMA, Health Canada, and ICH, as required, to ensure compliance
- Continuously develop and update knowledge of relevant regulatory requirements, guidance documents, and submission standards to support effective submission preparation.
- Keeps abreast of regulatory procedures and changes. May directly interact with regulatory agencies on defined matters.
- Contribute to development of process documentation including, SOPs, Work Instructions, or Best Practices
- Act as a liaison between regulatory operations and cross-functional stakeholders to address regulatory needs, ensure alignment on submission objectives, and communicate regulatory timelines.
- Facilitate communication between regulatory teams and other departments to ensure seamless submission and compliance processes.
- Assist in audit preparation by organizing documentation, ensuring regulatory submissions are audit-ready, and representing regulatory operations during inspections as needed.
Required Skills & Qualifications
- Bachelor’s degree in a scientific, technical, or regulatory-related discipline required.
- 8 - 10 years of experience in regulatory operations within the pharmaceutical or biotechnology industries, with a demonstrated track record in document and submission management.
- Extensive experience with Microsoft Word and StartingPoint templates to prepare technical documents.
- Proficient in migration to and maintenance of Veeva RIM. Expertise in Veeva implementation, customization, and support, including the ability to troubleshoot issues, train users, and drive process improvements.
- Understanding of publishing practices and related issues.
- Strong knowledge of FDA submission requirements, document formatting standards, and regulatory guidelines (FDA, EMA, ICH) to support submission accuracy and compliance.
- Proven ability to manage complex submissions, multitask, and meet tight deadlines.
- Experience with project planning tools and tracking systems to effectively coordinate regulatory timelines and maintain submission documentation.
- Excellent written and verbal communication skills, with a strong ability to clearly convey regulatory information to cross-functional teams.
- Ability to collaborate effectively with internal and external stakeholders and foster productive relationships with publishing vendors.
- Detail-oriented with a high standard of quality for regulatory submissions and document tracking.
- Strong analytical skills for troubleshooting issues within regulatory systems and ensuring submission quality.
- Demonstrated ability to be productive and successful in a fast-paced work environment.
$134,000 - $180,000 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 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