Careers

At LEXEO Therapeutics, we are a team focused on our people and our patients.

We are committed to be a best-in-class team that represents a community of life-long learners, being bold while demonstrating the values of integrity & respect

We are creative, collaborative, courageously pioneering & entrepreneurial

If you share in this passion, we invite you to join our team where we equally focus on experiences, talents, and diversity to advance therapies for those in need.

Director, Clinical Science

  • New York, NY, United States

  • Full Time

  • Experienced

Job Summary

Reporting to the VP, Clinical Science and Clinical Operations, the Associate Director/Director, Clinical Science is mainly responsible for the scientific and medical input into clinical trials and clinical projects and works hand-in-hand with Clinical Operations on the successful planning and conduct of one or more clinical trials (phase I -III).

The successful candidate will be highly collaborative, motivated and self-directed. The candidate must also possess impeccable communication and organizational skills, a high attention to detail and quality, intellectual curiosity, as well as strong initiative and ability to execute.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Preparation of the following documents: protocol and amendments, informed consent forms, clinical submission documents, clinical study reports
  • Development of clinical trial designs 
  • Presenting aspects of the trial during investigator meetings
  • Review of clinical trial data
  • Oversight of scientific activities outsourced to a Clinical Research Organization (CRO) 
  • Contribute to statistical analysis plans, data listings, (e)CRF, (e)diaries, operations manuals and external provider selection
  • Be an active participant in the review of provider specifications (e.g. ECG, central lab), clinical development plans, Investigator’s Brochure (IB) as well as the investigator and country selection
  • Perform other duties as required

Required Skills & Qualifications

  • MD, PhD, or PharmD with 2+ years industry experience in a position equivalent to Clinical Scientist in drug development
  • Gene Therapy, rare disease, and/or neurology experience in biotech company preferred 
  • Demonstrated ability to work independently and be a problem solver
  • Proven ability to perform key tasks
  • Organize work in a structured way with attention to detail and quality
  • Ability to work in a matrix and virtual team setting
  • Skilled at managing and prioritizing complex tasks
  • Excellent written and verbal communication skills
  • Collaborative and collegial work style

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

 

Apply now

Director / Senior Director, Clinical Physician – Cardiology

  • New York, NY, United States

  • Full Time

  • Senior Manager/Supervisor

Job Summary

Reporting to the Executive VP and Chief Medical Officer, The Medical Sr/Director will have direct responsibility for advancing high priority clinical programs in all stages of development for the cardiology therapeutic area. S/he will lead the development for one or more programs including both study strategy, protocol development and oversight of CROs and partners.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Oversee all clinical aspects of the cardiac gene therapy programs
  • Lead the clinical strategy for the cardiac gene therapy programs, working closely with regulatory affairs counterpart
  • Develop relationships with external experts and advisors 
  • Lead protocol development and drafting of protocols and amendments
  • Oversee conduct of clinical trials including start up, execution, and generation/interpretation of efficacy and safety results
  • Present clinical strategy and clinical trial data to management and other internal and external venues
  • Participate actively in regulatory agency interactions, contributing to document generation and participating in meetings with regulatory agencies
  • Oversee and mentor cardiac gene therapy clinical scientist(s)
  • Perform other duties as required

Required Skills & Qualifications

  • MD in cardiology with at least 5 years industry experience in drug development
  • Specialization in cardiology and/or industry experience in cardiac drug development 
  • Gene Therapy and/or rare disease experience in biotech company preferred 
  • Demonstrated ability to work independently and be a problem solver
  • Proven ability to lead strategy development
  • Organize work in a structured way with attention to detail and quality
  • Ability to work in a matrix and virtual team setting
  • Skilled at managing and prioritizing complex tasks
  • Excellent written and verbal communication skills
  • Collaborative and collegial work style
Apply now

Associate Director, Analytical Development

  • New York, NY, United States

  • Full Time

  • Mid Level

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home. Our office will be located near Madison Square Park.  This role will require an in-office presence.

Job Summary

Reporting to the Senior Director, Analytical Development, the Associate Director, Analytical Development will be responsible for developing and optimizing the production and purification 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.

Job Responsibilities

  • Perform process development and optimization for gene therapy manufacturing process and technology transfer.
  • Build in-house capability to support upstream and downstream development for viral vectors.
  • Acting as a Subject Matter Expert (SME), engage in proactive relationships with partners including CMO/manufacturing team, a person in a plant, batch record/SOP review.
  • Prepare manufacturing process data summary, process description, process report, and technology transfer reports.
  • Participate/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.
  • Assist with execution of process planning and resourcing critical material to ensure project progress aligns with the company timeline.
  • Familiar with applicable regulatory cGMP requirements for gene therapy.
  • Perform other duties as required.

Required Skills & Qualifications

  • Ph.D. in biochemistry or related + 8 yrs experience in biochemistry, life sciences, pharma sciences, chemical engineering or related; or Master + 12 yrs experience reqd. 3 yrs of experience must be working for pharma or biotech company
  • Experience working w/cell + gene therapy products
  • Pharma drug process validation + manufacture, and successful drug submissions
  • Strong knowledge of FDA, cGMPs, ICH guidelines and QBD principles

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

Apply now

Associate Director, Program and Portfolio Management

  • New York, NY, United States

  • Full Time

  • Experienced

Job Summary

Reporting to the VP, Portfolio and Program Manager, the Associate Director, Program and Portfolio Management, works in partnership with Program Teams to develop, facilitate approval, and execute on the project strategy across all phases of development. In alignment with the company’s portfolio strategy, this individual is responsible for managing one or more programs/project teams in both Research and Development areas. The successful candidate will be a proven leader with the experience and drive to work with key stakeholders to define and implement effective portfolio and project management methodologies.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast 

Job Responsibilities

  • Provide portfolio and project management support for the planning and execution of the company’s programs throughout their life cycle (discovery/acquisition to development and commercialization).
  • Work in partnership with program team leaders and other functional leaders to develop, facilitate approval, and execute the project strategy.
  • Organize the preparation of high-quality documents for review by governance committees in collaboration with project teams.
  • Participate actively in strategic discussions with functional leaders involving company priorities, business objectives and plans to meet these objectives.
  • Responsible for developing and maintaining integrated project plans targeting optimization of scope, timelines, resources and risks.
  • Responsible for accurate preparation and timely distribution of reporting tools for planning, tracking and trending of progress against plan at the project, program and portfolio levels.
  • Partner with Finance to define and maintain project budgets, ensuring the budget/LRP is built on a realistic and agreed upon set of operational assumptions, timelines and resource needs.
  • Support the development and update of life cycle plans.
  • Lead process improvement initiatives, identifying opportunities to enhance and implement portfolio and project management tools and methodologies.
  • Coordinate cross-functional efforts, such as organizing ad hoc working groups and advisory meetings when needed; always ensuring proper communication and alignment across functions.
  • Proactively identify project challenges and risks, propose, and implement mitigation/contingency plans, along with execute and/or monitor the execution of corrective actions.
  • Direct project communications and ensure all stakeholders are timely informed and knowledgeable of project activities, risks and challenges.
  • Ensures project work complies with established practices, policies and processes.
  • Perform other duties as required

Required Skills & Qualifications

  • BS degree in a scientific field with 8+ years of experience or MS degree in a scientific field with 5+ years of experience in a biotechnology or pharmaceutical setting.
  • Knowledge of FDA requirements, Good Clinical Practices, Good Manufacturing Practices and pharmaceutical product development.
  • Excellent understanding of principles, concepts, practices, and standards of pharmaceutical project management, preferably across multiple functional areas.
  • Advanced knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.
  • Strong leadership, communication and collaboration skills with proven ability to manage cross-functional projects, lead cross functional teams, and interact with Executive Management.
  • Ability to understand and communicate scientific and business elements associated with assigned projects.
  • Hands-on, “roll up your sleeves” approach toward achieving business results.
  • Strong communication skills both written and oral
  • Experience working in a fast-paced, entrepreneurial, development-stage company is highly desirable.

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

 

Apply now

Director / Senior Director, Clinical Physician - Neurology

  • New York, NY, United States

  • Full Time

  • Executive

Job Summary

Reporting to the Executive VP and Chief Medical Officer, The Medical Sr/Director will have direct responsibility for advancing high priority clinical programs in all stages of development for the neurology therapeutic area. S/he will lead the development for one or more programs including both study strategy, protocol development and oversight of CROs and partners.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Oversee all clinical aspects of the Neurologic gene therapy programs
  • Lead the clinical strategy for the Neurologic gene therapy programs, working closely with Regulatory affairs counterpart
  • Develop relationships with external experts and advisors 
  • Lead protocol development and drafting of protocols and amendments
  • Oversee conduct of clinical trials including start up, execution, and generation/interpretation of efficacy and safety results
  • Present clinical strategy and clinical trial data to management and other internal and external venues
  • Participate actively in Regulatory agency interactions, contributing to document generation and participating in meetings with Regulatory agencies
  • Oversee and mentor neurologic gene therapy Clinical Scientist(s)
  • Perform other duties as required

Required Skills & Qualifications

  • MD in neurology with at least 5 years industry experience in drug development
  • Specialization in neurology and/or industry experience in neurologic drug development
  • Gene Therapy and/or rare disease experience in biotech company preferred 
  • Demonstrated ability to work independently and be a problem solver
  • Proven ability to lead strategy development
  • Organize work in a structured way with attention to detail and quality
  • Ability to work in a matrix and virtual team setting
  • Skilled at managing and prioritizing complex tasks
  • Excellent written and verbal communication skills
  • Collaborative and collegial work style

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

 

Apply now

Executive Assistant and Office Administrator

  • New York, NY, United States

  • Full Time

  • Mid Level

Job Summary

The Executive Assistant and Office Administrator will support the Chief Executive Officer and other Executive level reports. The executive assistant will play an important role on the operational capacity of the executive leadership team as well as contribute to the daily flow and operational success of the company office. The successful candidate will have strong organizational and administrative skills, a high degree of professionalism, experience dealing with senior external stakeholders, and excellence in both written and oral communications. The ideal candidate is a critical thinker and a creative problem-solver.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home. Our office will be located near Madison Square Park.  This role will require an in-office presence, likely Mondays through Thursdays and as business needs dictate.

Job Responsibilities

  • When office is open, meets and greets visitors in a courteous and professional manner
  • Manage professional and personal scheduling for the executive team, including agendas, meetings, conference calls, travel arrangements and other company logistics.
  • Coordinate scheduling and calendar management
  • Manage, coordinate, and arrange senior executives’ travel and travel-related activities, including hotel booking, transportation, and meals
  • Perform administrative and office support, such as spreadsheets, PowerPoint presentations, mailing and shipping packages, and maintenance of filing system and contact/employee database
  • Maintain professionalism and strict confidentiality with all materials, and exercise discretion when interfacing with internal and external stakeholders
  • Organize team communications and plan events, both internally and offsite
  • Ensure office efficiency by maintaining appearance of common areas, identifying, and managing office supply needs, managing relationships with vendors and utilities, and coordinating food delivery, as needed
  • As the main point of contact in the reception area, oversee day-to-day activities of the office and provide answers, resources, and solutions, as needed
  • Prepare personal and company expense reports

Required Skills & Qualifications

  • Bachelor’s degree
  • 4+ years of experience as an Office Manager or Executive Assistant Knowledge, Skills, and Abilities
  • Strong organizational, problem-solving, and analytical skills; able to multi-tasking and to manage priorities and workflow
  • Ability to work independently and as a member of various teams and committees
  • Performs other duties as assigned by supervisor
  • Knowledge of office administration responsibilities, systems, and procedures
  • Dependable, flexible, ethical, and honest professional
  • Must be proficient with Microsoft Office
  • Excellent written skills with attention to detail, time management and organizational skills
  • Excellent interpersonal skills, with an ability to build relationships at all levels of the organization, including external contacts
  • Demonstrates a high level of professionalism in dealing with confidential and sensitive issues

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

Apply now

Director, Program and Portfolio Management

  • New York, NY, United States

  • Full Time

  • Experienced

Job Summary

Reporting to the VP, Portfolio & Program Management and Corporate Strategy, the Director, Program and Portfolio Management, works in partnership with Program Teams to develop, facilitate approval, and execute on the project strategy across all phases of development. In alignment with the company’s portfolio strategy, this individual is responsible for managing one or more programs/project teams in both Research and Development areas. The successful candidate will be a proven leader with the experience and drive to work with key stakeholders to define and implement effective portfolio and project management methodologies.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Leads and drives Program Core Teams, and is responsible for setting the direction for the Team and manage the execution and operational aspects of the program, including Development Plans, tactical implementation plans, integrated project timelines, monitoring key milestones and decisions points in order to drive project goals and objectives.
  • Interfaces with functional area representatives as well as groups to ensure timely execution of program activities, including anticipating and identifying project risks, mitigations, and contingencies as well as supporting timely action plans and issue resolution.
  • Represents the Core Team; ensures that the Development strategy is appropriately supported and aligned with the Target Product Profile (TPP); ensures key strategic decisions and recommendations are thoroughly vetted by Senior Leadership
  • Provide portfolio and project management leadership for the planning and execution of the company’s programs throughout their life cycle (discovery/acquisition to development and commercialization).
  • Organize the preparation of high-quality documents for review by governance committees in collaboration with project teams.
  • Participate actively in strategic discussions with functional leaders involving company priorities, business objectives and plans to meet these objectives.
  • Responsible for developing and maintaining integrated project plans targeting optimization of scope, timelines, resources and risks.
  • Responsible for accurate preparation and timely distribution of reporting tools for planning, tracking and trending of progress against plan at the project, program and portfolio levels.
  • Partner with Finance to define and maintain project budgets, ensuring the budget/LRP is built on a realistic and agreed upon set of operational assumptions, timelines and resource needs.
  • Support the development and update of life cycle plans.
  • Lead process improvement initiatives, identifying opportunities to enhance and implement portfolio and project management tools and methodologies.
  • Coordinate cross-functional efforts, such as organizing ad hoc working groups and advisory meetings when needed; always ensuring proper communication and alignment across functions.
  • Proactively identify project challenges and risks, propose, and implement mitigation/contingency plans, along with execute and/or monitor the execution of corrective actions.
  • Direct project communications and ensure all stakeholders are timely informed and knowledgeable of project activities, risks and challenges.
  • Ensures project work complies with established practices, policies and processes.
  • Perform other duties as required

Required Skills & Qualifications

  • MS/MBA/PhD in a scientific field with 10+ years of experience in a biotechnology or pharmaceutical setting, with at least 3 years in a senior level project management oriented leadership role.
  • Knowledge of FDA requirements, Good Clinical Practices, Good Manufacturing Practices and pharmaceutical product development.
  • Excellent understanding of principles, concepts, practices, and standards of pharmaceutical project management, preferably across multiple functional areas.
  • Advanced knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.
  • Strong leadership, communication and collaboration skills with proven ability to manage cross-functional projects, lead cross functional teams, and interact with Executive Management.
  • Ability to understand and communicate scientific and business elements associated with assigned projects.
  • Hands-on, “roll up your sleeves” approach toward achieving business results.
  • Strong communication skills both written and ora
  • Experience working in a fast-paced, entrepreneurial, development-stage company is highly desirable.

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

Apply now

Associate Director / Director, Regulatory Strategy - Regulatory Lead

  • New York, NY, United States

  • Full Time

  • Experienced

Job Summary

Reporting to the Head of Regulatory Affairs, the candidate will act as Regulatory Lead for our cardiac or neurological gene therapy programs work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements.  We are seeking a motivated and ambitious individual to provide leadership and support to regulatory activities to achieve our strategic vision.  In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. 

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Contribute to the development and implementation of regulatory strategies to facilitate the progress for assigned programs in all phases of development.
  • Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory submissions.
  • Actively participate in interactions with regulatory agencies for assigned programs.
  • Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global BLAs / MAAs.
  • Interact with Regulatory Affairs personnel within external service providers and development partner companies.
  • Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
  • Perform other duties as required

Required Skills & Qualifications

  • Bachelors or advanced degree in a scientific discipline, with a minimum of 4 years’ experience working in a regulated environment, at least 4 years of regulatory experience in the biopharmaceutical industry 
  • Experience a plus and experience with rare disease/ orphan drug development and gene therapy desirable.
  • Direct experience with pharmaceutical regulatory submissions, managing major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
  • Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
  • Demonstrated leadership and success in management of regulatory activities and interacting with regulatory agencies, including the FDA.
  • Excellent verbal and written communication skills.
  • Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
  • Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience is a plus.
  • Previous experience in successfully leading assigned activities within cross-functional teams.

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

 

 

Apply now

Regulatory Affairs Specialist

  • New York, NY, United States

  • Full Time

  • Entry Level

Job Summary

We are seeking a highly motivated individual to contribute to our Regulatory Affairs organization. This is an entry level position, ideal for a recent graduate with an advanced degree (such as a PhD or PharmD) with a strong desire to learn and develop in a dynamic, young company.  This individual will contribute to regulatory strategy and operations, submissions management, and medical writing for products in our pipeline.  This includes reviewing FDA and other health authority documents to understand current regulatory expectations, contributing to the writing and management of regulatory submissions, and providing input into the strategic direction of product development.  In addition to having a strong scientific background with experience or strong interest in gene therapy, the individual must have excellent written and verbal communication skills and have the ability to function effectively as an engaged team member in a fast-paced environment.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Summarize regulatory expectations through review of publications, regulatory guidance documents and regulations, and prior regulatory decisions
  • Contribute to regulatory processes and strategies
  • Read and understand technical reports and scientific studies
  • Author and review sections of regulatory documents
  • Coordinate and/or contribute to the compilation, review, and publishing of regulatory submissions in accordance with eCTD and global regulatory submission standards
  • Ensure accurate planning and tracking of submission activities and deliverables
  • Participate in Product Development Teams
  • Remain current on global regulatory submission guidelines and processes

Required Skills & Qualifications

  • Advanced degree in a scientific discipline related to biology and medicine with a preference for experience with gene therapy (e.g. PharmD, PhD)
  • Experience with project planning, presenting, conducting and interpreting scientific experiments or clinical, drug development, prescribing and labeling knowledge
  • Detail oriented with a high degree of organizational skills
  • Team player as demonstrated by strong interpersonal skills, including the ability to successfully navigate a professional environment
  • Excellent written and verbal communication skills with an emphasis on scientific writing
  • Ability to work with minimal supervision, to set priorities, and meet timelines
  • Proficient in Microsoft Office Suite (Outlook, Word, Project) and Adobe
  • Willingness to take on a variety of roles and responsibilities and the ability to manage multiple complex projects as needed in a startup environment

Recent college graduates, please include your transcript

Apply now

Vice President, Head of Clinical Operations

  • New York, NY, United States

  • Full Time

  • Executive

Job Summary

LEXEO is seeking an experienced and motivated professional to lead and build our Clinical Operations function as a key member of our development team. This individual will report to the Chief Medical Officer and will ensure that studies are completed on time and within budget in accordance with corporate objectives. This is a hands-on role and will be required to build excellent working relationships with various internal and external groups.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

  • Collaborate with the LEXEO CEO, R&D leadership, Weill Cornell research staff, LEXEO clinical and regulatory colleagues, CRO partners and other vendors to conduct clinical trials that meets corporate goals
  • Evaluate and develop optimal outsourcing model for implementation of trials including selection of CROs and other vendors/ external partners. Oversee development of requests for proposals, negotiate and approve contracts and work orders, and review invoices prior to submission for approval
  • Develop, maintain, and report on program budgets, including long-range forecasting, in support of LEXEO’s financial goals
  • Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct
  • Provide oversight of the CROs to avoid issues or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc.

Required Skills & Qualifications

  • BS/MS and 10+ years of experience in the pharmaceutical or biotech industry within clinical operations and trial management
  • Experience leading global clinical trials; rare disease/gene therapy trial experience preferred.
  • Thorough knowledge of development program management from IND- through NDA/BLA, including inspection readiness
  • Extensive experience in CRO/ vendor selection and oversight, budget projection and management, establishing clear milestones, ensuring high-quality data delivery and report generation
  • Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA
  • Experience working in a fast-paced environment
  • Excellent communication skills and ability to influence across multiple functions

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

Apply now