Based in New York City, Lexeo Therapeutics is a clinical-stage genetic medicines company dedicated to transforming healthcare by applying pioneering science to fundamentally change how disease is treated.  Building on groundbreaking research from Weill Cornell Medicine and the University of California San Diego, Lexeo partners with preeminent institutions on the cutting edge of gene therapy research.  Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4 associated Alzheimer's disease programs, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization. 

For more information, please visit www.lexeotx.com.

Lexeo Therapeutics

Operations

Support operational activities for clinical bio-sample management in gene therapy programs.

• Function as the subject matter expert to support the operationalization of clinical bio-sample activities across Lexeo’s clinical programs
• Independently collaborates across clinical study teams, functions, and departments
• Be the key point of contact for biosample activities keeping the teams informed to enable data driven decision making.
• Ensure efficient biosample logistics from study set-up through data delivery and study close-out
• Management of day-to-day operational routine activities delegated to biosample vendors including vendor management and oversight, performance management, escalation of issues
• Ensures standardization and harmonization of bio-sample processing and throughput activities across clinical trials for optimal sample accrual and quality
• In consultation with Bioanalyitcs teams, clinical study team, and other key stakeholders, provides input for lab vendor selection, lab vendor management and oversight of the long-term storage vendor
• Contributes to the budget development, review invoices against work completed, support financial accrual activities
• In consultation with Clinical Study Team, plans and co-ordinates delivery of bio-samples and associated data to align with trial objectives and critical trial operation milestones
• Knowledgeable of sample import/export requirements relative to study team’s country selection
• Co-creates and/or implements a program/trial level Clinical Operations Bio-sample management plan that aligns with trial/program objectives, and compliant with Lexeo SOPs, ICH/GxP/GLP/GDP
• Ensures development and availability of laboratories’ vendor management plans per Lexeo SOPs and established templates
• Provides input on relevant bio-sample information required for development of study Informed Consent templates
• Creates and/or leverages tracking systems to report progress, address issues and resolutions
• Oversees, facilitates, and tracks door-to-door sample disposition i.e., investigative sites, couriers, and laboratories for local/regional and global clinical trials of moderate to high complexity
• Anticipates, identifies, escalates, and provides actionable recommendations for issues that may impact bio-sample quality, analysis/data integrity, custody of samples, timelines, cost, etc
• Develops and/or leverages appropriate systems, standards, training modules, and processes to ensure quality and data integrity
• Other duties as assigned

Clinical Operations Bio-sample Manager - Contractor

Content Writer

• Lead the Medical Writing function at Lexeo
• Oversee development of clinical and regulatory documents
• Manage medical writing resources
• Contribute to process improvement initiatives
• Serve as the Medical Writing Lead for clinical development programs
• Draft and direct writing of company regulatory and clinical documents

Director/Senior Director, Medical Writing

Executive Assistant

• Extensive coordination and scheduling of internal and external meetings, conference calls, and video conference meetings, utilizing Outlook and Video Conferencing on behalf of supported Executives
• Manageonsite and offsite meetings, including arranging for any catering and document distribution, IT needs
• Prioritize Outlook calendar items and resolve calendar conflicts, informing Executive of meeting changes and keeping them on schedule throughout the day
• Coordinate set up and clean up of conference rooms
• Management of international and domestic travel, meeting coordination, expense reports and logistics for the executive(s), and triaging changes as they arise
• Act as the point of contact among executives, employees, clients, and other external partners
• Manage information flow in a timely and accurate manner
• Support office management needs as they arise
• Assist other Admins. in firm-wide tasks when requested
• Organize and maintain the filing of relevant documents


Lexeo Therapeutics Jobs in New York City