Careers

Primary Responsibilities

• CMC Strategic Planning: Develop and implement CMC strategies to support preclinical product development, clinical trial material manufacture and supply, late-stage development, validation, BLA preparation, launch activities and commercialization. For both pre-clinical and clinical stage projects provide expert guidance on CMC program timelines, risk management, and resource allocation.  Harness the strengths of functional areas, establish a cohesive integrated development strategy, set clear team goals 
• Project Management: Lead and manage CMC workstreams, including tracking of milestones, coordinating cross-functional teams, and ensuring timely completion of deliverables.   Preparation and execution of comprehensive Project and Development plans and associated documents for each project ensuring the requirements for all relevant areas are achieved. Lead project team meetings. Maintain CMC RAID, “Risks, Actions, Issues, and Decisions” log, project plans and dashboards.  
• Operational Excellence: Optimize CMC processes and workflows to improve efficiency, quality, and compliance. Identify and address operational bottlenecks, implement best practices, and facilitate continuous improvement initiatives. 
• Regulatory Support: Collaborate with Regulatory Affairs to prepare CMC sections of regulatory filings (INDs, CTAs, BLAs). Ensure documentation meets global regulatory standards and supports successful submissions. 
• Vendor and Partner Management: Support relationships with CDMOs, contract testing laboratories and other external partners. Ensure clear communication of requirements, monitor performance, and facilitate resolution of issues. Incorporate third party timelines into Lexeo Tech Ops integrated project plans 
• Budget and Resource Coordination: Support budgeting, forecasting, and resource planning for CMC activities. Track expenditures and provide status updates to Technical Operations leadership. 
• Reporting and Communication: Prepare and present project updates, dashboards, and reports for internal and external stakeholders. Support the communication of CMC strategy and progress effectively across teams. 

Required Skills & Qualifications

• Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree preferred. 
• Minimum of 8 years’ experience in CMC operations, strategy, or project management within the biotechnology or pharmaceutical industry.    
• Proven track record in managing CMC initiatives for clinical-stage or commercial products. 
• Strong understanding of gene therapy, biologics, or advanced therapies manufacturing and regulatory requirements. 
• Exceptional organizational, communication, and analytical skills. 
• Excellent leadership, emotional intelligence, and communication skills 
• Ability to work independently and in a fast-paced, dynamic environment. 
• Experience with external vendor management and cross-functional collaboration.  

Apply now

Key Responsibilities

• 
  
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 

Apply now

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. 

Apply now

Primary Responsibilities

• In partnership with Lexeo leadership, build a world-class capital markets program, overseeing all messaging, external communications, and investor engagement strategy 
• Partner with the CEO, CFO, and senior leadership on quarterly earnings, roadshows, analyst days, and capital markets initiatives 
• Coordinate preparation of investor-facing materials: earning scripts, Q&A prep, press releases and corporate presentations 
• Serve as a spokesperson for the company with institutional investors and analysts
• Monitor sell-side coverage, investor sentiment, peer activity, and sector dynamics to anticipate market reactions 
• Build and maintain sophisticated financial models, comps, and valuation scenarios to inform both investor messaging and internal decision-making 
• Provide leadership with insights into market opportunities, risks, and investor priorities. 
• Prepare and/or deliver investor-informed readouts of clinical, operational, and R&D data to executives and the Board. 
• Advise internal teams on framing pipeline milestones, trial timelines, and value drivers for Wall Street. 
• Partner with leadership to refine pipeline and corporate strategy through the lens of investor expectations. 
• Coordinate quarterly earnings process end-to-end, including script, deck, Q&A prep, and messaging 
• Manage investor conferences, non-deal roadshows, analyst days, and targeted outreach programs 
• Ensure all external communications comply with SEC and regulatory requirements 
• Conduct benchmarking of peers’ pipelines, valuation frameworks, and investor narratives. 
• Translate insights into actionable recommendations for internal strategy and external messaging 

Required Skills & Qualifications

• Bachelor’s degree in finance, economics, business, or life sciences required; MBA or CFA strongly preferred. Medical or scientific background a plus.  
• 7-10 years in capital markets, investor relations, equity research, investment banking, or corporate strategy 
• Biotech/pharma experience preferred; must demonstrate ability to interpret and communicate complex clinical data 
• Proven track record of direct engagement with institutional investors, analysts and capital markets stakeholders  
• Strong financial modeling, valuation, and market analysis expertise 
• Exceptional communication and executive presence, with ability to influence both internal leaders and external stakeholders 

Apply now