Careers

• New York, NY, United States

• Full Time

• Experienced

Role Summary

Reporting to the Director of Research and also supporting Director of Bioanalytical and Quality, this position will provide the hands-on help in the research lab to execute development of various bio-analytical assays and sample analysis from in vitro, in vivo discovery and development studies related to AAV-based cardiac gene therapy programs

Location

This role requires an in office / lab presence at our NYC office located 345 Park Avenue South.

Primary Responsibilities

• Cell culture including maintenance of several cell line, transfection, cell engineering, DNA/RNA/protein analysis.
• Analysis of AAV vector expression in tissues following gene therapy, involving DNA, RNA and protein extraction and quantification.
• Development of bio-analytical assays including bio-distribution using qPCR, expression assays via ELISA/ECL, Westerns, and other specific biomarker assays for cardiac based AAV gene therapies
• Sample analysis for proof of principle, proof of concept and non-GLP IND-enabling studies across all cardiac programs.  
• Work very closely with supervisor and assist in reviewing protocols, writing reports, memos and support technical transfer of assays to CRO at the right time.
• Assist with relevant literature search and summarizing guidance/information as needed for all studies including various animal disease models.
• Assist with financial support activities including contracts, invoices, forecasting for non-clinical studies.

Required Skills & Qualifications

• BS with 8+ years, MS with 5+ years or Ph.D. with 2+ years in life sciences, pharmaceutical sciences, biochemistry, or equivalent
• Industry and/or CRO experience in assay development is a plus.
• Technical excellence in bio-analytical assays development as well as analysis independently is a must.
• Strong track record in developing qPCR, RT-qPCR, ELISA, and Westerns is a must.   
• Strong knowledge of scientific concepts and techniques such as molecular biology, protein biochemistry, and cell biology is also a must. Experience in gene therapy is desired.
• A working knowledge of scientific software such as excel, Graph Pad, image analysis etc. is desirable.
• Experience in writing SOPs, reports, memos etc. and ability to facilitate technical transfer for assays developed in the lab to CRO is desirable.
• Cross functional acumen and highly skilled in working with complex issues and troubleshooting is strongly desired.
• Results oriented, has a bias for action. Strong initiative, accountability, and willingness to take ownership and drive projects to completion.
• Accustomed to “roll up their sleeves” and execute multiple tasks needed in a small company environment.
• This position requires extremely high collaborative and Team-oriented skills, understanding sense of urgency, multi-tasking ability, passion to thrive in challenges, and desire to strive in a fast-paced environment.

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $115,000 - $150,000 per year.

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

• New York, NY, United States

• Full Time

• Mid Level

Role Summary

Reporting into the Director, Clinical Operations, the Clinical Trial Manager provides the day-to-day operational management of LEXEO’s clinical stage programs. The function provides the operational expertise and leadership to one or more clinical study teams to ensure the effective and efficient delivery 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 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 impeccable communication and organizational skills, a high attention to detail and quality, as well as strong initiative and execution.

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

• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Perform ongoing vendor management during the study, including review of performed work against budget, negotiation of scope of work, budget amendments, performance management and issue resolution in close collaboration with the Director, Clinical Operations
• Provide input on operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
• Participate in study start-up activities including protocol authoring, database design, study manuals, essential documents etc. to ensure the operational team is poised for successful data to enable the study strategy
• Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
• Lead site selection, patient recruitment and retention activities
• Author documents necessary for study initiation and execution; ensure other documents and manuals are provided for study initiation and execution
• Manage drug and clinical supply needs
• Work closely with study sites/vendors to ensure timely and appropriate shipping of samples
• Communicate regularly with the CRO to ensure data are being cleaned and coded appropriately and in a timely fashion
• Ensures the completion and finalization of any corrective and preventive action plans resulting from audits and inspections
• If required coordinates/provides input to Regulatory Affairs for responses to study questions or issues from Health Authorities
• Coordinates responses to study questions or issues from IRBs/IECs
• Accountable for overall TMF in the trial
• Ensures study adherence to ICH/GCP/FDA regulations and SOPs

Required Skills & Qualifications

• Bachelors or Master’s degree required. Field of study within life sciences or equivalent.
• Minimum of 4+ years’ experience in clinical research with at least 2 years’ experience in study management.
• Site monitoring/CRA experience is required
• Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a global environment, working with vendors and/or CROs, drug supply management and planning operational activities
• Biotech experience preferred
• Experience of project managing operational aspects of a clinical study including development of timelines and budgets
• Excellent knowledge of GCP regulations (ICH and US FDA regulations)
• Well-developed written and verbal communication skills demonstrated by ability to present clear instruction/direction
• Excellent written and verbal communications skills
• Analytical and problem-solving capabilities
• Collaborative and collegial work style
• Attention to detail and follow-up

Anticipated Salary Range

Depending on qualifications and overall experience, base salary is likely to be $125,000 - $155,000 per year.

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

• 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.

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

• 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.

• 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.