Associate Director, Clinical Trial Management
New York Bio Connect, New York, New York, us, 10261
Role Summary
The Associate Director, Clinical Trial Management (AD, CTM), in collaboration with the clinical operations program leader, will define the clinical operations strategy and be responsible for country and global execution of complex clinical trials end-to-end consistent with the clinical plan. The AD, CTM will be responsible for partnering with internal and external business functions and vendors throughout the life cycle of one or more clinical study(ies) in accordance with company SOPs, ICH/GCP, and all applicable local regulations. Candidates for this role must champion a culture of quality and continuous process improvement.
Primary Responsibilities
Designs and aligns operational plans to study and company objectives; balances short-term needs with long-term goals Provide overall management of day-to-day operations of assigned study (ies) to ensure completion per established program goals Lead cross-functional teams (pre-clinical development, clinical pharmacology, safety, regulatory affairs, clinical supply, biometrics, legal, and medical affairs) and ensure vendors (e.g., CROs, labs, etc,) are compliant with contracted scope of work Establish the clinical trial budget and collaborate with CRO(s) and finance colleagues to forecast and track the financial status of the program against approved budget Perform ongoing vendor management and oversight 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 Head of Clinical Operations and Project and Portfolio organization Ensure rigor and availability of documentation to demonstrate sufficiency of sponsor oversight Review and contribute to operational plans including risk-based approaches to site monitoring, fit for purpose strategies for patient recruitment and retention, patient diversification targets, vendor and site reporting requirements, risk identification and mitigation strategies, trial budgets, site selection, and clinical supplies management Provide operational input for operational risk assessments, including patient and site burden, diversity considerations during the protocol development process and database design Contribute to the initial development of the study timelines, deployment of allocated resources, budget, risk and quality plans, elevate issues that may jeopardize time, cost, and the quality of study deliverables Lead the preparation of vendor requirements, including the definition of project scope, confirmation of vendor qualification, and subsequent selection of key partners. Be responsible for the study team health, including collaborative partners. Oversee feasibility assessments with input from Clinical Development Lead and other relevant cross-functional partners towards the optimal selection of countries and clinical sites Ensure inspection readiness at all times Author, audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; ensure other documents and manuals (pharmacy, laboratory, and operations manuals/plans) are sufficiently clear and available for study initiation and execution Work closely with study sites/vendors to ensure timely and appropriate processes for obtaining, and shipping of sample viability for analysis and data generation Monitor and communicate with the CRO to ensure data currency i.e., cleaned and coded appropriately to meet all program milestones Ensure appropriate reporting, documentation, completion, and finalization of any corrective and preventive action plans resulting from audits and inspections If required, coordinate/provide input to Regulatory Affairs for responses to study questions or issues from Health Authorities Coordinate responses to study-related questions or issues from IRBs/IECs Accountable for the overall integrity of the TMF for each respective trial Ensure study adherence to ICH/GCP/FDA regulations and SOPs Function as a lead on LEXEO’s Clinical Operation initiatives Other clinical operation activities that are delegated by Clinical Operations Leadership Required Skills and Qualifications
Advanced degree (MS/PhD, PharmD) in life sciences preferred with a minimum of 6 years clinical trial management experience Biotech industry experience preferred Strong knowledge of ICH/GCP/FDA regulations, site monitoring/CRA experience is required Proven clinical study management skills, and experience of the operational aspects of all stages of clinical studies, including the development of timelines and budgets. Preferably working in a global environment, working with vendors and/or CROs, drug supply management and planning operational activities Experience with complex/rigorous study designs 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 Ability to travel to domestic and/or international sites as needed Ability to travel quarterly to New York City HQ
$153,000 - $211,000 a year Compensation is dependent on qualifications and experience 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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Primary Responsibilities
Designs and aligns operational plans to study and company objectives; balances short-term needs with long-term goals Provide overall management of day-to-day operations of assigned study (ies) to ensure completion per established program goals Lead cross-functional teams (pre-clinical development, clinical pharmacology, safety, regulatory affairs, clinical supply, biometrics, legal, and medical affairs) and ensure vendors (e.g., CROs, labs, etc,) are compliant with contracted scope of work Establish the clinical trial budget and collaborate with CRO(s) and finance colleagues to forecast and track the financial status of the program against approved budget Perform ongoing vendor management and oversight 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 Head of Clinical Operations and Project and Portfolio organization Ensure rigor and availability of documentation to demonstrate sufficiency of sponsor oversight Review and contribute to operational plans including risk-based approaches to site monitoring, fit for purpose strategies for patient recruitment and retention, patient diversification targets, vendor and site reporting requirements, risk identification and mitigation strategies, trial budgets, site selection, and clinical supplies management Provide operational input for operational risk assessments, including patient and site burden, diversity considerations during the protocol development process and database design Contribute to the initial development of the study timelines, deployment of allocated resources, budget, risk and quality plans, elevate issues that may jeopardize time, cost, and the quality of study deliverables Lead the preparation of vendor requirements, including the definition of project scope, confirmation of vendor qualification, and subsequent selection of key partners. Be responsible for the study team health, including collaborative partners. Oversee feasibility assessments with input from Clinical Development Lead and other relevant cross-functional partners towards the optimal selection of countries and clinical sites Ensure inspection readiness at all times Author, audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; ensure other documents and manuals (pharmacy, laboratory, and operations manuals/plans) are sufficiently clear and available for study initiation and execution Work closely with study sites/vendors to ensure timely and appropriate processes for obtaining, and shipping of sample viability for analysis and data generation Monitor and communicate with the CRO to ensure data currency i.e., cleaned and coded appropriately to meet all program milestones Ensure appropriate reporting, documentation, completion, and finalization of any corrective and preventive action plans resulting from audits and inspections If required, coordinate/provide input to Regulatory Affairs for responses to study questions or issues from Health Authorities Coordinate responses to study-related questions or issues from IRBs/IECs Accountable for the overall integrity of the TMF for each respective trial Ensure study adherence to ICH/GCP/FDA regulations and SOPs Function as a lead on LEXEO’s Clinical Operation initiatives Other clinical operation activities that are delegated by Clinical Operations Leadership Required Skills and Qualifications
Advanced degree (MS/PhD, PharmD) in life sciences preferred with a minimum of 6 years clinical trial management experience Biotech industry experience preferred Strong knowledge of ICH/GCP/FDA regulations, site monitoring/CRA experience is required Proven clinical study management skills, and experience of the operational aspects of all stages of clinical studies, including the development of timelines and budgets. Preferably working in a global environment, working with vendors and/or CROs, drug supply management and planning operational activities Experience with complex/rigorous study designs 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 Ability to travel to domestic and/or international sites as needed Ability to travel quarterly to New York City HQ
$153,000 - $211,000 a year Compensation is dependent on qualifications and experience 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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