Careers

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, escalate 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   

Primary Responsibilities

• Contribute to the development of and manage execution of the medical affairs patient engagement plan aligned with program goals and key deliverables 
• Maintain and cultivate trust-based relationships with patient advocacy organizations, consistent with the phase of development of Lexeo clinical programs, to enable collaboration across shared goals 
• Liaise with external agencies to ensure program execution and delivery including content development to support department strategies 
• Provide internal stakeholders with actionable insights gathered from interactions with patient advocacy groups
• Collaborate with Clinical Development and Clinical Operations to support development of asset-specific pre-launch readiness patient materials needed to optimize launch execution  
• Implement patient engagement programs that include educational programs, patient speaker engagement, advisory councils, and clinical trial awareness  
• Support congress planning and logistics including identifying opportunities for onsite engagement, booth presence and materials creation
• Manage social media channel development and creation of digital assets to support it 
• Works to amplify the culture of Lexeo as a trusted partner to patients 
• Represent Lexeo at patient community meetings and events where appropriate 
• Ensure all Lexeo employees have an opportunity to learn about patient perspective and Lexeo’s commitment to the communities we serve
• Adhere to Lexeo Therapeutics’ values, culture, and policies

Required Skills and Qualifications

• RN, NP, PA, PharmD or other healthcare-associated roles in life sciences with experience working directly with patients and/or patient communities; rare disease, cardiac and/or gene therapy experience preferred
• Minimum 3 years of relevant experience at manager-level responsibilities
• Interest and capacity to learn and understand program science. Gene therapy experience and/or cardiac disease experience highly desirable
• Ability to interpret key scientific data and translate findings into patient-friendly language to meet educational and research needs
• Strong interpersonal, presentation, and communication skills, and demonstrated ability to work collaboratively in a dynamic, fast-paced, team-oriented environment and to prioritize activities based on quickly changing information
• Excellent project management skills with the ability to manage multiple projects and teams with shifting timelines
• Strong PowerPoint presentation and design skills preferred
• Ability to travel approximately 30% within the US and globally, including quarterly to NY HQ
• Ability to work Eastern time zone
• Ability to work up to 25 hours per week, with the possibility of increased hours as needed

Primary Responsibilities

• Leverage scientific expertise to establish and maintain strategically impactful relationships with national, regional, and local Key Opinion Leaders (KOLs) and other healthcare providers (HCPs) for Lexeo’s cardiac gene therapy pipeline, in alignment with medical strategy
• Proactively and reactively engage KOLs and HCPs on various topics, including disease state education, mechanism of action, emerging and existing clinical data, and the evolution of treatment landscapes for Lexeo’s cardiac gene therapy pipeline
• Support asset-specific pre-launch readiness and optimize launch execution through the attainment of impactful field medical metrics
• Provide internal stakeholders with actionable medical insights gathered from scientific interactions with HCPs
• Explore new areas of scientific and clinical interest to understand unmet needs, how the landscape is evolving, and how Lexeo’s pipeline programs may address those needs
• Collaborate with Clinical Development and Clinical Operations to support clinical trial sites and investigators as needed
• Stay current on medical and scientific developments in related therapeutic areas by continuously reviewing literature, monitoring competitor activities, networking with experts, and attending assigned scientific congresses and symposia
• Complete accurate and timely administrative responsibilities, including reports, projects, and required documentation
• Deliver approved medical and scientific presentations to internal and external stakeholders
• Support evidence generation efforts by facilitating external investigator-sponsored research (ISR) concept submissions
• Regularly collaborate with field-based and cross-functional colleagues to advance clinical practice in a compliant manner
• Support medical and scientific training of cross-functional teams as needed
• Adhere to Lexeo Therapeutics’ values, culture, and policies. 

Required Skills and Qualifications

• MD, DO, PhD, PharmD, other doctorate degrees relevant to the role, RPh, NP, PA, other APPs, and/or a Master’s degree in life sciences with clinical research experience in neuromuscular or cardiac disease
• 3+ years of field experience in the biotech or pharmaceutical industry, OR 2+ years and launch experience, OR direct patient care experience in cardiology or neurology
• Gene therapy experience preferred, particularly in the neuromuscular space
• Ability to interpret key scientific data and translate findings to meet educational and research needs
• Strong interpersonal, presentation, and communication skills, and demonstrated ability to work collaboratively in a dynamic, fast-paced, team-oriented environment

Primary Responsibilities

• Own the coordination and execution of all clinical supply-related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for clinical programs 
• Support IWRS User specifications and UATs 
• Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs 
• Manage supplier relationships with vendors   including maintaining key performance metrics and budget/invoice tracking, review supply needs for study start-up, ongoing resupply strategies, contract negotiation, amendments and closeout requirements 
• Evaluate vendor selection to support clinical study supply chain according to capability and fit 
• Generate RFPs for vendor proposals with the ability to breakdown study protocols to support the supply strategy and communicate study needs to obtain vendor based budgeting or internal support 
• Contribute program budget review and invoicing considerations as it relates clinical supply chain study management and capture any impacts 
• Support the clinical program’s global supply chain in current and future clinical studies for clinical supply to commercial strategy.  Oversee international depots and distribution as appropriate 
• Support governance committees for global clinical operations and global clinical supply chain 
• Ensure consistency across processes and develop tools to implement sustainable improvements 
• Manage the execution of clinical supply strategy for specific clinical programs from early to late stage development with an understanding of commercial launch readiness 
• Understand the roles and responsibilities of all functions represented on cross functional drug development teams to mitigate up and downstream operational deliverables. 
• Support regulatory filings including IND and BLA submission information as it relates to a global supply chain 
• Provide regular updates to the TMF as per departmental requirements that comply with all regulatory requirements. 
• Participate in clinical study team meetings, align with study details, collaborate in meeting study objectives, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development) 
• Additional responsibilities as needed 

Required Skills and Qualifications

• Bachelor's degree in life sciences, business-related field, or supply chain management; Master’s degree in Supply Chain Management preferred 
• Minimum 5 years of experience handling/leading clinical supply chain and logistics; development experience preferred; 10+ years experience (7 years experience with Master’s degree) for Associate Director level 
• Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management strongly preferred 
• Knowledge of clinical materials production processes and design strategy for patient dose kits supporting a clinical study design 
• Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams 
• Demonstrated ability to work in a highly matrixed environment and manage supply chain initiatives in a high performing team across all levels 
• Experience in multi-functional areas (Clinical Operations, Medical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP 
• Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment 
• Extensive in planning and execution of investigational materials supply strategies 
• General knowledge of GxP principles is required 

Key Responsibilities

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Quality Leadership & Strategy 
• Develop and execute a scalable GxP Quality Assurance strategy aligned with Lexeo’s business goals and regulatory expectations. 
• Serve as the senior Quality leader across GMP, GCP, GLP, and GVP functions. 
• Advise executive leadership on quality risks, mitigation strategies, and inspection readiness. 
• Foster a proactive quality culture rooted in continuous improvement, accountability, and operational excellence. 
• Build, mentor, and develop a high-performing Quality team that reflects Lexeo’s values of scientific rigor and collaboration 


Quality Systems Development 
• Establish and maintain a phase-appropriate Quality Management System (QMS) establishing a document hierarchy including a Quality Manual, policies, SOPs and other documents needed to support a virtual gene therapy organization with early and late stage programs. And, also enabling a QMS that can support a registrational study and commercial launch. 
• Ensure quality systems effectively support clinical development, pharmacovigilance, all CMC activities, translational sciences, clinical biomarker development, and external partnerships 
• Oversee implementation and maintenance of an electronic QMS (eQMS) to support scalability and compliance 


Regulatory Compliance 
• Lead and/or provide leadership support for GCP, GLP, GMP and GVP quality activities, including internal and external audits, vendor oversight, deviation investigations, and quality agreements, health authority inspections. 
• Support clinical trial operations by ensuring all aspects of ICH GCP are followed (e.g., protocol adherence, data integrity, and informed consent compliance) 
• Oversee early and late phase manufacturing QA activities, including batch record review, product release, and disposition in collaboration with CMC and Technical Operations 
• Drive inspection readiness and represent Lexeo during regulatory inspections and partner audits 
• Establish procedures for surveying regulatory intelligence and disseminate throughout Lexeo. 


Vendor and Partner Oversight 
• Oversee and management of a risk-based vendor qualification program including performance of external audits, and ongoing compliance monitoring of CROs, CDMOs, testing laboratories, and other GxP service providers 
• Ensure robust Quality Agreements and alignment of standards and expectations across all external partners 


Cross-functional Collaboration 
• Partner closely with Clinical Development, Regulatory Affairs, Technical Operations, Supply Chain, and Research to ensure quality is embedded throughout the product lifecycle 
• Serve as the QA representative on governance bodies and cross-functional development teams, ensuring risk-based decision-making and clear communication of quality principles 

Qualifications

• Bachelor’s degree in a relevant scientific discipline (Biology, Chemistry, Engineering, or related field); advanced degree preferred 
• 12–15+ years of experience in Quality Assurance within the biotech or pharmaceutical industry, with significant exposure to both GMP and GCP environments 
• Proven leadership in building and scaling GxP quality systems within a clinical- to commercial-stage setting 
• Strong knowledge of FDA, EMA, and ICH regulations and inspection practices 
• Experience in regulatory submissions, from IND to BLA, in support of CMC and clinical components 
• Experience managing audits, CAPAs, deviations, and regulatory inspections 
• Demonstrated success leading external partnerships (CROs, CDMOs) 
• Excellent communication, collaboration, and problem-solving skills with the ability to influence across functions and levels 
• Strategic thinker who can balance regulatory rigor with Lexeo’s innovative, fast-paced biotech environment 

Preferred Experience

• Experience with AAV-based gene therapy or biologics 
• Familiarity with global clinical trial operations and pharmacovigilance practices 
• Proven ability to lead cross-functional quality teams in a growth-stage organization 

Primary Responsibilities

• Design and execute proof-of-concept genetic medicine studies in cell lines, primary cells, iPSC-derived cells and animal models 
• Design and oversee in vitro and in vivo pre-clinical studies to evaluate the efficacy and safety of genetic medicine strategies with CROs and external partners 
• Develop and execute assays for in vitro and in vivo phenotypic outcomes using next-generation sequencing (NGS), PCR, qPCR, flow cytometry, Western blots and/or ELISA 
• Analyze and interpret data and present to internal and external audiences 
• Contribute to the scientific efforts and develop innovative solutions by maintaining a broad understanding of the field 

Required Skills and Qualifications

• PhD degree (in life sciences or related discipline) and at least 2 years of industry or postdoc experience or MS degree with at least 4 years of relevant experience in industry or academia 
• Extensive experience with mammalian cell culture including primary human cells is required, culturing of iPSCs and iPSC-derived cardiomyocytes is a plus 
• Technical experience in genomics and molecular and cellular biology (NGS, PCR, qPCR, flow cytometry, Western blots, ELISA) 
• Familiarity with drug discovery for genetic medicines  
• Ability to multi-task and excel in a fast-paced environment 
• Excellent troubleshooting, written/verbal communication and project management skills 
• Proficiency with applications used for scientific data analysis (e.g., GraphPad, MS, JMP, etc)