Vice President, Clinical Operations

@ Lexeo Therapeutics
Lexeo Therapeuticslexeotherapeutics.com

Vice President, Clinical Operations

Posted 2 months ago

This job is still taking applications, but it's been up a while.

About the job

Lexeo is a genetic medicine company in NYC focusing on gene therapies for inherited cardiovascular diseases. The VP leads clinical trials, vendor management, and budgets, impacting innovative treatments.

Requirements

  • 10+ years pharma/biotech experience
  • Experience leading global trials
  • Knowledge of IND to NDA process
  • Vendor and budget management
  • Understanding GCP, FDA, ICH

Qualifications

  • Advanced degree preferred
  • Experience in rare disease trials
  • Strong communication skills
  • Ability to work in fast-paced settings

Full job description

Role 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.


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

  • Collaborate with Lexeo CMO, R&D leadership, Weill Cornell research staff, Lexeo clinical, quality, and regulatory colleagues, CRO partners and other vendors to conduct clinical trials that meet 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 and Qualifications

  • Advanced degree preferred 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




    • About Lexeo


    Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.

    Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.

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




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