Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

Lead and build the Clinical Operations function as a key member of the development team. Report to the Chief Medical Officer, ensuring studies are completed on time and within budget, aligning with corporate objectives. This hands-on role requires building strong relationships with internal and external groups. Contribute to an entrepreneurial environment, making a meaningful impact on clinical trial progress for novel gene therapies.

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 meeting corporate goals
Evaluate and develop optimal outsourcing models for trial implementation, including selecting CROs and external partners
Oversee development of requests for proposals, negotiate and approve contracts and work orders, and review invoices for approval
Develop, maintain, and report on program budgets, including long-range forecasting, to support Lexeo’s financial goals
Monitor study-specific timelines and key deliverables, implementing strategies to optimize trial conduct efficiency
Provide oversight of CROs to prevent issues or rapidly adapt to challenges in feasibility/start-up, recruitment, resourcing, and site management

Skills

Thorough knowledge of development program management from IND- through NDA/BLA, including inspection readiness
Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA
Excellent communication skills
Ability to influence across multiple functions

Location

New York City office
Remote

Work Type

Hybrid model
2 days/week in office
3 days working from home

Experience Level

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
Extensive experience in CRO/vendor selection and oversight
Extensive experience in budget projection and management
Extensive experience in establishing clear milestones
Extensive experience in ensuring high-quality data delivery and report generation
Experience working in a fast-paced environment

Education Level

Advanced degree preferred

Salary/Compensations

$300,000 - $350,000 a year
Compensation is dependent on qualifications and experience

About the Company

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
Lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia
Broader pipeline addresses 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

Equal Opportunity

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