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 Scientist, Gene Therapy

New York, NY, United States
Full Time
Senior Manager/Supervisor

Role Summary

The Clinical Scientist is responsible for providing scientific input during protocol development, study design, oversight of clinical aspects of study conduct, and interpretation of study results through the final study report. The Clinical Scientist will work closely with other members of the clinical development and operations teams to execute and deliver milestones. The successful candidate will be highly collaborative and motivated, with excellent knowledge of first-in-human clinical trial design, preferably with experience in gene or cell therapy. The candidate must also possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.

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!

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.

Primary Responsibilities

Contributes to creation of clinical development strategic plan, clinical trial design, electronic case report forms (eCRFs), and statistical analysis plans
Preparation (or oversight of vendor preparation) of protocols and ancillary study documents, case report forms, operations manuals, investigator’s brochures, and operations manuals in collaboration with Clinical Operations Director
Preparation (or oversight of vendor preparation) of data table, listings, figures, clinical study reports and clinical submission documents
Close collaboration with clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation
Close collaboration with clinical operations team to review relevant vendor, CRO and site scopes of work, study budgets, and plans or manuals related to study data, IVRS, central labs, etc.
Development of internal and external training materials and presentations
Review and analysis of interim and final clinical trial data, including summarizing potential safety and efficacy trends, for study documents including CSRs, IBs, and DSURs
Close collaboration with clinical development physician in strategic planning and conduct of investigator meetings and advisory boards
Close collaboration with clinical development physician in preparation of abstracts, manuscripts, presentations, and materials for external meetings as related to the protocol and/or clinical program
Oversight of scientific activities outsourced to vendors and clinical research organizations

Required Skills & Qualifications

Relevant clinical or biomedical Ph.D. or relevant Pharmacy, Nursing or MSc/MRes degree
At least 5-10 years of drug development or medical research experience within the biopharmaceutical industry; candidates with only academic experience may be considered
Excellent knowledge of clinical trial design, statistics, and data review tools
Significant experience in development of protocols and case report forms
Ability to share scientific data effectively across functions and through presentations
Significant experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends
Excellent knowledge of ICH and FDA GCP Guidelines
Experience working in global regulatory and pharmacovigilance environments preferred
Demonstrated ability to think analytically and strategically, work independently and solve problems
Highly motivated, accountable, self-directed, and able to execute with attention to detail
Excellent communication and interpersonal relationship skills including negotiating and relationship management skills across multiple functions and with external vendors
Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style
Patient-focused with a deep commitment to understanding patient needs
Gene therapy and/or rare disease experience in biotech company preferred
Enjoy being part of a growing team and fast-paced environment

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $180,000 - $220,000 per year.

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

Apply now

Director, Clinical Operations, Gene Therapy

New York, NY, United States
Full Time
Senior Manager/Supervisor

Role Summary

Reporting to the Vice President of Clinical Operations, this role will provide the day-to-day operational management and leadership to one or more clinical study teams to ensure the effective and efficient delivery, in accordance with timelines and budget, of all required activities for clinical studies through all phases of Clinical Study Management (Plan/ Prepare, Initiate, Conduct, Close out), in accordance with the appropriate quality standards including LEXEO SOPs, ICH/GCP and applicable regulations. The successful candidate will be highly collaborative, motivated, with excellent knowledge of GCP regulations (ICH and US FDA regulations) and experienced in overseeing Clinical Research Organization (CROs) and other vendors. The candidate must also possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution.

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.

Primary Responsibilities

Delivery of the clinical trial on-time and in accordance with the approved budget
Day-to-day operational management of CROs and other study vendors including review of performed work against budget, negotiation of scope of work and Change Orders, performance management and issue resolution in close collaboration with the VP, Clinical Operations
Develop and oversee implementation of operational plans and activities including site selection, site monitoring plans, risk mitigation plans, and communication plans
Coordination with clinical supplies management
Management and oversight of trial budget including forecasts and resource allocation
Development and management of study timelines, risk management plans and quality plans
Timely notification to management of challenges/risks/delays to study timelines, resources, budget, and compliance
Implementation and finalization of any corrective and preventive action plans resulting from audits and inspections
Timely coordination with Regulatory Affairs in connection with responses to study questions or issues from Health Authorities
Timely coordination of responses to study questions or issues from IRBs/IECs
Oversight and management of overall quality and completion of the TMF
Execution of study in adherence to ICH/GCP/FDA or other relevant regulatory authority regulations and SOPs
Other duties as required

Required Skills & Qualifications

Scientific degree or other comparable degree or scientific education
At least 5-10 years of study management or CRO management experience, including operational aspects of all stages of clinical studies as well as development of timelines and budgets
Excellent knowledge of GCP regulations (ICH and US FDA regulations)
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 including negotiating and relationship management skills across multiple functions and with external vendors
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
Biotech experience preferred; must enjoy being part of a growing and fast-paced environment
Experience working within a global environment preferred

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $180,000 - $220,000 per year.

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

Apply now