Careers

• New York, NY, United States

• Full Time

• Mid Level

Role Summary

The Associate Director, Corporate Finance will play an integral role in a critical function directly supporting LEXEO’s mission.  The candidate will work closely with the Senior Director, Corporate Finance and Strategy to oversee all aspects of financial planning and analysis related to LEXEO’s operations. The candidate must have proven ability to facilitate management dialogue and decision making through fact-based analysis and evaluation of alternatives. The role will support operational aspects, financial close, analysis, budgeting and forecasting at the program and department level. The individual will be responsible for ongoing financial management of the business and will provide the organization with decision support analysis. Additionally, the individual will support both capital markets activities and strategic financial analysis, including capital expenditures and cash forecasting. The individual will play an integral role in enabling operational success of the company’s strategic priorities and will partner across the organization to ensure transparency on financial initiatives in support of LEXEO’s objectives.

This individual is a key member of the team responsible for ensuring sufficient resource planning to meet corporate objectives with financial discipline and acts as a key advisor to the business teams with an ability to model complex operating scenarios.

Location

Our work culture 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.

Primary Responsibilities

• Responsible for full financial support of department budgets and G&A costs
• Develop business cases, cost plans and financial insights to assist leadership in making sound investment decisions
• Support monthly and quarterly accounting review and financial close as necessary
• Responsible to achieve financial goals and elevate issues proactively, timely, and transparently
• Support implementation of financial planning and analysis tools as necessary
• Support long-term financial planning of the company and strategies to appropriately access the capital markets
• Contribute to creation of a high-performance culture through effective leadership and communication with key stakeholders in the cross-functional organization
• Articulate a vision for the finance function and communicate a supporting strategy with clarity, force and impact to align people, critical resources, management and stakeholders
• Support and lead process changes that continuously adapt to a dynamic business environment
• Business-partnering with Project Management, Clinical Operations, Preclinical, CMC, Business Development, and G&A teams to enable transparent understanding of LEXEO financial position

Required Skills & Qualifications

• Prior pharmaceutical / biotech industry experience
• A track record in finance to enable a culture of excellence and financial rigor

Depending on qualifications and overall experience, base salary is likely to be $140,000 - $175,000 per year.

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

• New York, NY, United States

• Full Time

• Mid Level

Role Summary

Reporting to the Senior Director, Analytical Development and Quality, the Scientist provides leadership in the development of analytical assays related to AAV-based gene therapy programs. This includes development of cell based and molecular (e.g. qPCR/ddPCR) assays and establishing the mechanism-of-action of AAVs in cellular systems using novel approaches. This position requires collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. We are an early-stage company, so this is a highly visible and impactful role in our organization. 

Location

LEXEO Office located in New York, NY.

Primary Responsibilities

• Development of phase-appropriate testing methodologies – including such assays as digital PCR, potency, quantitative PCR – for AAV gene therapy vectors
• Assist in the development and internal testing of potency assays in a target-specific manner.
• Building in-house capability in analytical development for viral vectors
• Assist in driving the analytical strategy of the organization and support regulatory activities for filing 
• Assist in collaborating with CDMOs and CROs to support production and release of GMP materials 
• Participate in technical transfer between laboratories, qualification/validation of assays and QC activities for material release
• Timely development of assays as well as testing of samples for material release
• Identification and communication of risks in assay performance and their mitigation
• Provide support to the organization regarding analytical aspects, e.g. regulations, compliance and current industry best practices

Required Skills & Qualifications

• BS with 4+ years, MS with 2+ years or Ph.D. in chemistry, biochemistry, life sciences, pharmaceutical sciences, chemical engineering or equivalent
• Experience in cell and gene therapy products.
• Experience with pharmaceutical drug-process validation and manufacture a plus
• Knowledge of FDA, cGMPs, and ICH guidelines and QBD principles a plus
• Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity. Results oriented with breadth and depth in pharmaceutical development and commercial products to resolve complex problems
• 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

Depending on qualifications and overall experience, base salary is likely to be $110,000-$125,000 per year.

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

• New York, NY, United States

• Full Time

• Mid Level

Role Summary

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 members of the clinical development and operations teams to execute and deliver milestones.  The successful candidate will be highly collaborative and motivated, with excellent knowledge of first-in-human clinical trial design, preferably with experience in gene or cell therapy.  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.

Location

Our work culture 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.

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 physician in strategic planning and conduct of investigator meetings and advisory boards
• Close collaboration with clinical development physician 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

Required Skills & Qualifications

• Relevant clinical or biomedical Ph.D. or relevant Pharmacy, Nursing or MSc/MRes degree
• 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 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

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $180,000 - $220,000 per year.

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

• New York, NY, United States

• Full Time

• Experienced

Role Summary

We are seeking a highly motivated Senior Accountant to join our growing team. As Senior Accountant, you will be the primary preparer of most accounting workpapers and support, reporting to the Assistant Controller and working with the AP Specialist. This is an exciting opportunity to contribute to the advancement of cutting-edge medical treatments and shape the future of healthcare.

Location

Our work culture 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.

Primary Responsibilities

• Participate in the monthly and annual accounting closing processes and contribute to producing accurate and timely financial statements;
• Prepare all recurring monthly journal entries;
• Maintain all balance sheet reconciliations and update monthly to ensure accurate reporting;
• Provide detailed fluctuation analysis for month end closing;
• Maintain effective internal controls and prepare annual internal control process narratives and key control analysis;
• Assist AP Specialist in proper coding of invoices;
• Ensure financial records are maintained in compliance with GAAP;
• Support financial statement audits and reports;
• Collaboration with operational personnel on financial and operational matters; and
• Special projects and other assignments as required.

Required Skills & Qualifications

• BA/BS degree in Accounting or related field
• 3-5 years of experience in an Accounting role
• Ability to work effectively with all levels of an organization
• Strong analytical skills with a high level of accuracy and attention to detail
• Ability to manage competing priorities and deadlines and strong problem-solving skills
• Strong written and verbal communication
• Intermediate or Advanced aptitude in Excel is required
• CPA or equivalent (or on-track) preferred
• Experience with a Big 4 or national firm, SEC registered company and/or Biotech company is preferred
• Familiarity with NetSuite and FloQast a plus

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $90,000 - $115,000 per year.

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

• New York, NY, United States

• Full Time

• Entry Level

Role Summary

Reporting to the Director, Process Development, this position will be responsible for developing and optimizing the production of AAV products in the lab and with collaborators with the goal of advancing the development of novel targets for cardiac and neurodegenerative disorders. As an early hire at a new company, you will have exposure to senior management, and you will be influential in championing and developing LEXEO’s culture. You will have an opportunity to learn in a fast-paced startup company, while working collaboratively within a multidisciplinary team that is dedicated to the development of new therapies.

Location

LEXEO Office located in New York, NY

Primary Responsibilities

• Perform process development, process characterization and scale-up activities to enable high productivity, scalable and robust upstream processes for viral vector manufacturing.
• Serve as a subject-matter-expert for the upstream process development of viral vectors using stirred-tank bioreactor technologies.
  and/or
• Serve as a subject-matter-expert for the downstream process development of viral vectors using chromatographic technologies.
• Design and execute laboratory studies to evaluate novel technologies to improve existing processes and establish manufacturing platforms.
• Engage in proactive relationships with partners including CMO/manufacturing team, a person in a plant, batch record/SOP review.
• Collaborate closely with the analytical team to evaluate critical gene therapy product characterization, critical quality attributes and process performance parameters, product characterization, and product release for gene therapy AAV vector production.
• Prepare manufacturing process data summary, process description, process report, and technology transfer reports.
• Assist with execution of process planning and resourcing critical material to ensure project progress aligns with company timeline.
• Familiar with applicable regulatory cGMP requirements for gene therapy.

Required Skills & Qualifications

• BS/MS degree with 0-2+ years of relevant experience in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, Microbiology, or related fields
• Hands-on experience of upstream cell culture processes and stirred-tank bioreactor technologies to manufacture biologics or viral vectors or vaccines.
  and/or
• Hands-on experience of downstream processes and chromatographic technologies to manufacture biologics or viral vectors or vaccines.
• Excellent communication and presentation skills, capable of conveying complex technical information in a clear, thorough, and influential manner is required.
• Excellent MS Office skills with a specific focus on word, excel and power point applications to author technical reports and presentations.

Depending on qualifications and overall experience, base salary is likely to be $75,000-$85,000 per year.

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