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

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

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