Director, Clinical Operations

Role Summary
The Director, Clinical Operations serves as the Program Lead and is expected to own and drive the  optimal operational strategy that aligns with program objectives, provide leadership and oversight to the study execution teams, and make high-quality decisions to ensure successful study execution of one or more clinical studies that are part of the program. Decisions should be made in accordance with the appropriate quality standards including Lexeo SOPs (Standard Operating Procedures), ICH/GCP and applicable regulations. The Director, Clinical Operations must possess excellent leadership and communication skills, be solution-oriented, operate with execution bias, exhibit high attention to detail and quality, as well as have strong initiative to drive functional strategy.
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. A remote working model may be considered for exceptional candidates. 
Primary Responsibilities

• Provide oversight and leadership support to the clinical team’s execution of the operational strategy while ensuring alignment with program timelines and approved budget, delivering high-quality data
• Strategic oversight informed by study(ies) status, teams’ trending assessments and other relevant information, streamlining and eliminating unnecessary obstacles, agile in risk detection, making tough decisions and acting on risks, issues etc. having a direct impact on quality, cost, timelines, and resources
• Inspire and motivate others towards a shared purpose setting clear strategies and robust implementation plans
• Timely reporting and escalation of relevant information to senior leadership
• Oversee teams’ documentation and sponsor oversight of outsourced study related activities
• Responsible and accountable for overall Clinical Operations program budgets, evaluating changes in scope and budget, budget burn rate, invoice accuracy, timely forecasting and delivery of financial information required by Lexeo financial, consulting with VP, Clinical Operations as appropriate
• Collaborate with Core team’s cross-functional partners providing Clinical Operations expertise input on country and site selection, operational feasibility, site and patient burden, and inclusion and diversity strategies.
• Ensure Clinical Operations Execution team have relevant operational plans in place, implemented, and in compliance per Lexeo SOPs, GCP (Good Clinical Practice), ICH (International Conference on Harmonization)
• Identify Clinical Operations’ resource needs, deployment, performance, development of line reports and other Clinical Operations staff in collaboration with VP, Clinical Operations
• Foster and support strong relationships with cross-functional partners, vendors, and sites
• Oversee timely coordination with Regulatory Affairs in connection with responses to study questions or issues from Health Authorities
• Oversee inspection readiness activities, ensure adherence to ICH/GCP/FDA regulations and Lexeo policies and SOPs
• Oversee implementation and documenting of quality events in QMS and finalization of any corrective and preventive action plans resulting from audits and inspections
• Provide input and drive functional growth and strategy, identifying opportunities for process and other improvements

Required Skills & Qualifications

• Minimum of BA/BS in a scientific field or other comparable degree or scientific education
• At least 10 years of Clinical Operations leadership and management experience to include at least 4 ys of global study management responsibility within pharma/biotech or CRO (Clinical Research Organizations)
• Direct line management experience of Clinical Operations staff preferred
• Experience in gene therapy experience highly desirable
• Ability to travel ~ 25% both domestically and internationally
• Demonstrated ability to think analytically and strategically, work independently and be a problem solver
• Highly motivated and accountable, self-directed, and able to execute with attention to detail and follow-up
• Excellent communication and interpersonal relationship skills
• Skilled at leading and motivating teams to prioritize tasks and deliver on deadlines in a highly collaborative and collegial work style
• Patient-focused with a deep commitment to understanding patient needs

Anticipated Salary RangeDepending on qualifications and overall experience, base salary is likely to be $170,000 - $245,000 per year.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.

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