Careers

Primary Responsibilities

• Manage and lead the day-to-day operations of assigned study (ies) to ensure completion per established program goals
• Manage and 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
• Support the establishment of the clinical trial budget and coordinate 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

• BA/BS degree with 5 plus years clinical trial management experience and/or an advanced degree (MS/PhD, PharmD) with at least 2 years of study management experience. Biotech experience preferred and a degree in life sciences or equivalent
• Strong knowledge of ICH/GCP/FDA regulations site monitoring/CRA experience is required
• Experience with gene therapy and GMO and IBC submissions 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 
• 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

• 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

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

• Build, lead, and scale the marketing function; manage budget, resources, vendor/agency relationships, and KPIs tied to demand generation and launch readiness 
• Develop and execute integrated brand and launch planning strategies for Lexeo’s cardiac pipeline (initially US-focused and future global expansion) 
• Shape and evolve Lexeo’s brand story as a leader in genetic cardiovascular medicine, partner with external communications (media, PR, social, thought leadership, IR) 
• Build deep customer segmentation and personas across key stakeholders: opinion leaders, cardiologists, genetic specialists, patient advocacy groups, and other members of multi-disciplinary care teams 
• Lead disease awareness and diagnosis-activation initiatives in partnership with Medical and Patient Affairs 
• Define evidence needs and value propositions for payer engagement, pricing, and provider strategies 
• Contribute to strategic planning and commercial prioritization across the portfolio 
• Develop messaging frameworks for HCPs, patients, and payers, emphasizing genetic causes, durability, and impact of therapies. 
• Expand Lexeo commercial infrastructure with an eye towards commercial launches, including data and analytics, field reporting, patient support and commercial intelligence 
• Serve as the commercial voice on cross-functional teams, ensuring alignment from early stage through launch 
• Collaborate with new and growing field teams, including market access, medical affairs, field reimbursement and sales 

Required Skills & Qualifications

• Bachelor’s in Life Sciences, Marketing, or Business required; MBA, PharmD, or PhD preferred. 
• 10+ years in life sciences marketing or launch planning (rare disease, gene therapy, advanced biologics), with both upstream (strategy, portfolio) and downstream (brand, digital) experience. 
• Experience in developing launch readiness for novel therapies (cell/gene therapies, biologics in rare/monogenic disease); experience in specialty/high-science areas is preferred 
• Strong scientific acumen; familiarity with AAV platforms, manufacturing, and regulatory pathways. 
• Deep competency in digital/omnichannel marketing: CRM, automation, SEO/SEM, analytics, content strategy. 
• Strong cross-functional collaboration skills and ability to influence senior leadership 
• Ability to translate complex science into compelling commercial narratives 

Primary Responsibilities

• Conduct market research, including primary and secondary research, to outline market dynamics in FA, ACM and across other genetic medicine targets, such as unmet needs, key stakeholders, existing treatment paradigms, and competition, focusing on the U.S. and key international markets. 
• Leverage research and insights to define how the company’s gene therapy candidates may meet unmet needs and impact future treatment paradigms. 
• Collaborate closely with clinical colleagues to understand target product profiles and identify patient populations eligible for treatment. 
• Identify and map key stakeholders involved in the treatment of FA and ACM, as well as those involved in the potential administration of cardiac gene therapy. 
• Compile information on current treatment costs, payer perspectives, patient coverage types, treatment expenditure, and other medical costs. 
• Analyze commercially available gene therapies in key markets, identifying successful constructs that maximize patient access or enable value-based reimbursement. 
• Outline recommended investments and timelines for commercial scale-up over the next three years, including necessary commercial capabilities and colleagues. 
• Develop and implement operational plans to ensure the efficient execution of commercial and corporate strategies. 
• Support senior executives and business development colleagues with corporate strategy initiatives such as pipeline prioritization and development strategy optimization and other organizational planning 
• Monitor and evaluate the performance of commercial initiatives, providing insights and recommendations for continuous improvement. 
• Advance Lexeo objectives commercially, including support for corporate communications, media awareness, and internal employee initiatives that increase knowledge and understanding of lead programs and strategies 
• Work closely with colleagues in Clinical Development, Medical Affairs, Program Management, and other relevant departments to ensure cohesive strategy execution. 
• Report to the Senior Director of Commercial Marketing, regularly updating on project progress and strategic recommendations. 
• Present findings and strategic recommendations to company leadership, facilitating informed decision-making. 

Required Skills & Qualifications

• MBA with 7-10 years of professional experience in consulting, finance, marketing, sales, or biopharmaceuticals, with a focus on commercial strategy and operations. 
• Experience in the healthcare and biopharmaceutical industry, with a deep understanding of global biopharmaceutical market trends. 
• Proven ability to synthesize data from multiple sources and distill insights into clear, actionable business strategies. 
• Strong project management skills with meticulous attention to detail and the ability to manage multiple priorities in a fast-paced environment. 
• Excellent interpersonal communication skills and a track record of successful cross-functional collaboration. 
• Ability to operate independently, driving projects to completion with minimal oversight. 

Primary Responsibilities

• Lead work plans (SOWs) by working with department leaders, key stakeholders and CROs following the principles of Good Laboratory Practices (GLPs/21 CFR 58), where applicable, and company Standard Operating Procedures (SOPs)
• Coordinate meetings with vendors to ensure agendas are appropriate for the discussion, ensure meeting minutes are documented, follow-up on action items, and provide status updates to the internal teams
• Liaise with bioanalytical leads to ensure bioanalysis is well coordinated with in-life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period
• Monitor the study plan, timelines, and progress of study deliverables against forecasted timelines and budget and escalate issues that impact the study plan or budget in an effective and transparent manner
• Work closely with quality assurance to ensure compliance is checked as appropriate
• Summarize key findings of data as well as relevant scientific publications in presentations for internal review
• Work closely with Medical Writing and contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs 
• Coordinate with other internal and external stakeholders, including Clinical, CMC, Regulatory Affairs, and Finance and Accounting teams

Required Skills & Qualifications

• BS with 10+ years, MS with 8+ years or Ph.D. with 4+ years in life sciences, pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences or equivalent 
• Experience in AAV gene therapy products for minimum of 2 years   
• Working knowledge of GLP and ICH guidelines  
• Experience managing studies and authoring non-clinical sections of regulatory documents, particularly pre-INDs and INDs 
• Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity
• 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 the tasks needed in a small company environment
• A demonstrated sense of urgency and ability to work independently and under tight deadlines is required
• This position requires collaborative skills, strong interpersonal communication, multi-tasking ability, passion to thrive in challenges, and desire to strive in a fast-paced environment