Careers

Primary Responsibilities

 
Provide clinical development leadership for assigned programs, including late-stage (Phase 2/3 and/or registrational) studies in rare disease and gene therapy.
Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing, and Clinical Operations to shape an integrated development plan aligned with program objectives and BLA strategy.
Lead clinical strategy and oversight of protocol development, endpoint selection, eligibility criteria, safety monitoring approach, and clinical rationale to support health authority interactions.
Serve as a clinical leader for investigator and external expert engagement, including KOL interactions, advisory boards (as applicable), and site relationships to support enrollment and high-quality study conduct.
Drive cross-functional issue resolution and risk management for study execution; ensure decisions are documented and aligned with quality standards and inspection readiness.
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs).
Lead and/or mentor team members through matrix leadership; support a culture of accountability, collaboration, and scientific rigor. 

Required Skills and Qualifications

PhD, PharmD, or MD with a minimum of 6 years experience in industry (8 years for Senior Director), including 5 - 6 years of progressive experience within clinical development and late-stage trial delivery.
Proven experience leading late-stage (Phase 2/3 and/or registrational) development for rare disease programs.
Demonstrated experience supporting regulatory submission readiness, including BLA filing activities (e.g., clinical deliverables coordination, inspection readiness support, and cross-functional alignment).
Thorough knowledge of development program management from IND through NDA/BLA, including audit/inspection readiness.
Experience partnering with Clinical Operations and CROs/vendors to deliver high-quality data and documentation, including milestone management, budget awareness, and reporting/CSR support.
Advanced working knowledge of relevant guidelines and regulations (including ICH, GCP, and FDA requirements).
Ability to operate effectively in a fast-paced environment with shifting priorities and timelines.
Excellent communication skills and demonstrated ability to influence across multiple functions and levels, internally and externally. 

Key Responsibilities

AI/ML Strategy + Delivery  

Define and execute Lexeo’s applied AI/ML roadmap across discovery and development, prioritizing use cases that improve speed, quality, and decision confidence. 

Deliver solutions that are internal-only (e.g., scientific decision support, operational forecasting) and those that are generated internally but external-facing (e.g., partner-ready analyses (regulatory dossiers, briefing books, protocols etc.), validated dashboards, and decision materials).

Establish best practices for model lifecycle management (validation, documentation, monitoring, retraining), especially where outputs influence scientific decisions or regulated workflows. 

Advanced Analytics + Predictive Modeling 

Lead development and selection of appropriate ML approaches (e.g., XGBoost, Random Forest, SVMs, and other advanced models) based on problem framing, data constraints, interpretability needs, and deployment context.

Build and oversee predictive analytics using real-world data, including robust evaluation design, bias/variance trade-offs, and performance monitoring. 

Small Data Excellence + Synthetic Controls  

Apply techniques to amplify signal-to-noise in smaller datasets (e.g., regularization, Bayesian methods, hierarchical modeling, augmentation, multimodal integration, careful feature engineering, uncertainty quantification).

Guide strategy for synthetic control arms and comparable approaches (as appropriate), ensuring methodological rigor, transparency, and fit-for-purpose use in decision-making. 

Drug Discovery / Translational Partnership 

Translate drug discovery and translational questions into testable analytical hypotheses; partner with bench scientists to design data capture that enables strong modeling.

Serve as a bridge between scientific teams and data/engineering, ensuring solutions are scientifically credible and operationally adoptable. 

Cross-functional Enablement + Platform Integration 

Partner with stakeholders across R&D, CMC, Clinical, Safety, and IT/Security to implement scalable data pipelines and AI-enabled workflows.

Contribute leadership to current and emerging initiatives such as AI workflow automation/database buildouts and analytics agents that leverage enterprise platforms (examples already in motion include CMC AI automation, MaxisAI clinical database/AI efforts, and AI work to ingest historical data into Dataverse/Fabric for agent-based analysis; integration work such as a Benchling AI API initiative may also be in scope depending on priorities). 

External Partner/Vendor Leadership 

Liaise with external partners to evaluate tools, define statements of work, and deliver solutions—while ensuring knowledge transfer and sustainable internal ownership.  

Operational Excellence 

Improve internal processes through automation and analytics, focusing on measurable impact (cycle time, error reduction, throughput, decision latency).

Establish practical governance for data quality, documentation, and fit-for-use standards aligned with the realities of biopharma environments (including where regulated practices apply). 

What Success Looks like (First 6-12 Months)

A prioritized AI/analytics roadmap tied to measurable R&D outcomes; clear ownership and delivery cadence.

2–4 production-grade analytics solutions adopted by teams (internal and/or external-facing outputs as needed).

A repeatable approach for small datasets and high-noise signals; documented modeling standards and review practices.

Strong partner engagement model: vendors/partners used strategically, with internal capability building and durable outcomes. 

 

Required Skills and Qualifications

Advanced degree in a quantitative or scientific discipline (PhD strongly preferred; MS with exceptional experience considered).
10+ years of relevant experience across applied data science/ML in life sciences/biopharma (or adjacent domain with direct drug discovery translation), including 5+ years leading teams and influencing senior stakeholders.
Deep familiarity with advanced ML methods (including XGBoost, Random Forest, SVMs) and the judgment to select and justify the right tool for the job.
Demonstrated experience building predictive models with real-world, imperfect datasets and delivering them into production or decision workflows.
Proven ability to improve processes and operationalize analytics—moving beyond prototypes to adoption.
Strong cross-functional communication: can partner with scientists, engineers, and executives; can explain model performance and limitations clearly. 

Preferred Skills and Qualifications

Direct experience in drug discovery, translational research, and/or R&D decision support (target ID/validation, MoA, biomarker strategy, preclinical data integration).
Experience with small data strategies, causality-aware thinking, and synthetic control arms or closely related methodologies.
Experience operating in regulated/quality-sensitive environments and building documentation practices that scale (particularly relevant where validation and traceability are required).
Familiarity with enterprise data platforms and modern analytics stacks (lakehouse/warehouse patterns, feature stores, MLOps, model monitoring).

Primary Responsibilities

Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing activities
Support product specification lifecycle management, including establishment, justification, trending, revision, and regulatory impact assessment
Partner with Analytical Development and Technical Operations to support method qualification, validation, transfer, verification, and continued performance monitoring across testing laboratories
Serve as QC subject matter expert for laboratory investigations, including OOS, OOT, atypical results, assay failures, and method performance events
Support reference standard qualification, lifecycle management, and analytical comparability initiatives
Provide technical oversight for method transfers, comparability assessments, and laboratory readiness
Collaborate with Regulatory Affairs and CMC teams to author and review regulatory submissions, responses to health authority inquiries, technical reports, and analytical sections of INDs, BLAs, and other global filings
Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents
Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements
Collaborate with cross-functional CMC teams to align on sample submission and testing needs

Required Skills and Qualifications

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology); advanced degree (MS) a plus
6+ years of experience  or 4+ with Master’s (Sr. Manager level: BS + 8 years or MS + 6 years experience) in Quality Control, Analytical Development, Manufacturing Sciences, Quality Assurance, or related CMC functions within biotechnology or pharmaceutical organizations
Experience supporting late-stage development, process validation, and/or commercial readiness activities preferred
Experience supporting biologics, cell therapy, gene therapy, or other advanced therapeutics preferred
Strong understanding of cGMP regulations and global regulatory expectations applicable to analytical testing and Quality Control
Experience with analytical method lifecycle management, including qualification, validation, transfer, verification, and continued performance monitoring
Knowledge of analytical techniques commonly used for AAV and biologic products (i.e., ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, compendial safety testing)
Strong understanding of analytical control strategy development and specification management

Primary Responsibilities

Independently design and optimize analytical methods involving in-vitro cell culture and AAV transduction to demonstrate potency of the gene therapy vectors
Assist in the timely development and internal testing of CQAs, including potency assays, in a target-specific manner
Generate high-quality, reproducible data to support assay qualification, validation, method transfer, and QC-related activities for GMP material release
Analyze, interpret, summarize, and communicate findings through technical reports and presentations that clearly describe the scientific problem, relevant literature, experimental procedures, observations, and conclusions 
Assist in driving analytical strategy and support regulatory submissions in collaboration with internal groups across CMC, Quality, and CROs
Identify technical risks related to assay performance, evaluate relevant factors, and develop mitigation strategies, novel processes, or alternative approaches to solve problems and support continuous improvement
Collaborate on and review technical documentation and protocols to support late-phase assay validation projects at respective CDMO/CROs
Maintain accurate laboratory records and ensure compliance with company policies and regulatory standards
Apply industry best practices, regulatory expectations, and quality standards related to analytical development for gene therapy products, exercising judgment within generally defined practices and policies when selecting methods and techniques
Apply results and learnings from previous studies, and assimilate knowledge or techniques from adjacent scientific fields, to address new or different problems and achieve project goals
Collaborate and build constructive relationships across departments; serve as a technical resource and provide scientific coaching and technical guidance within project teams

Required Skills and Qualifications

BS in Biology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 6-8 years of relevant experience (MS with 4-6 years or PhD with 1-3 years of relevant industry experience)
Experience in cell and gene therapy products
Strong hands-on experience with tissue culture, analytical assay development and execution, data analysis, and troubleshooting
Experience with pharmaceutical drug-process validation and manufacture a plus
Knowledge of FDA, cGMP, and ICH guidelines and QBD principles a plus
Strong organizational skills, attention to detail, and data accuracy
Excellent communication, collaboration, and problem-solving skills with the ability to work effectively across functional teams
Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity. Results oriented with breadth and depth in pharmaceutical development and commercial products to resolve complex problems
Results-oriented, with strong initiative, accountability, and willingness to take ownership of projects, deliver milestones, and drive work to completion
Familiarity with electronic laboratory notebook and inventory systems such as Benchling or Quartzy preferred 

Primary Responsibilities

Design, execute, and lead process development and optimization studies for AAV manufacturing using Sf9 cells/baculovirus and HEK platforms.
Perform hands-on laboratory work to execute process development and optimization experiments, generate critical process data, and support technical troubleshooting.
Support and, as appropriate, define study designs to drive process optimization, scalability, robustness, and technology transfer for clinical and late-stage programs.
Collaborate with and provide technical leadership across upstream, downstream, analytical, manufacturing, and quality teams to evaluate process performance and product quality.
Support or own late-stage CMC deliverables, including process characterization, risk assessments, control strategy development, technology transfer, and validation readiness.
Author, review, and provide technical input for study protocols, technical reports, and regulatory documentation.
Support or lead troubleshooting, investigations, mentoring of junior staff, and continuous process improvement initiatives. 

Required Skills and Qualifications

Master’s degree in biochemical engineering, bioprocess engineering, molecular biology, cell biology, or relevant life sciences or engineering discipline with a minimum of 6 years of relevant experience, or PhD with at least 3 years of relevant experience.
Hands-on experience with upstream AAV production using Sf9 cells/baculovirus and HEK platforms required.
Understanding of virus/viral vector properties and experience with development of upstream and downstream processes for viral vectors or gene therapy products are highly desirable.
Working knowledge of downstream processing and analytical testing preferred.
Experience supporting process optimization, characterization, and late-stage CMC activities preferred.
Demonstrated leadership in process development, cross-functional collaboration, and late-stage CMC readiness is expected.
Experience authoring and reviewing regulatory documentation preferred. 

Primary Responsibilities

Define and lead the global Medical Affairs strategy across Lexeo’s portfolio, ensuring alignment with development milestones and business objectives
Build, mentor, and lead a high-performing Medical Affairs organization, including external partners and future in-house team members
Own scientific communications strategy, including publications planning, congress strategy, medical education, and dissemination of clinical and disease-state insights
Establish and oversee external engagement strategy with key opinion leaders, investigators, medical societies, and patient advocacy organizations
Serve as the senior Medical Affairs representative in cross-functional governance, partnering with Clinical Development, Regulatory, Market Access, and Patient Advocacy leaders
Guide medical input into clinical development plans, patient identification strategies, launch readiness planning, and evidence-generation priorities
Oversee medical review processes and ensure high-quality, compliant externally facing scientific content and response materials
Lead advisory board strategy and execution, translating stakeholder insights into actionable plans for development and commercialization
Represent Lexeo externally at major scientific meetings, investigator forums, and executive-level partner interactions
Drive the development of onboarding, scientific training, and internal medical education initiatives to elevate organizational disease-area expertise
Lead medical evidence generation and align the same with company objectives 

Required Skills and Qualifications

Advanced degree in life sciences, medicine, or a related field required (MD, PharmD, PhD preferred) with 10+ years of industry experience
Significant Medical Affairs leadership experience in biotechnology or pharmaceuticals, with demonstrated progression in scope and responsibility
Deep expertise in scientific communications, external expert engagement, medical strategy, and cross-functional collaboration
Experience building or scaling Medical Affairs capabilities in a growth-stage organization, especially on transitioning from clinical stage to commercialization, is strongly preferred
Strong executive presence with excellent written and verbal communication skills and the ability to influence senior internal and external stakeholders
Ability to operate strategically while remaining hands-on in a fast-paced, evolving environment
Experience with real world datasets and studies
A working knowledge of how to incorporate artificial intelligence and machine learning principles into medical affairs 

Primary Responsibilities

Provide strategic leadership and operational oversight for the Quality Management System (QMS), Document Control, and Training functions
Serve as the business owner and subject matter expert for the electronic Quality Management System (eQMS), ensuring system performance, compliance, and continuous improvement
Lead the development, review, approval, implementation, and lifecycle management of Standard Operating Procedures (SOPs), work instructions, policies, and quality records
Oversee document control processes, including document issuance, revision control, archival, and periodic review
Manage GxP and non-GxP training programs, ensuring timely assignment, completion, effectiveness, and compliance with regulatory expectations
Develop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement
Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other cross-functional teams to ensure quality system effectiveness
Support internal audits, external audits, regulatory inspections, and supplier audits related to Quality Systems, documentation, and training
Ensure Quality Systems remain aligned with FDA, EMA, ICH, and applicable global regulatory requirements
Lead and mentor Quality Systems personnel, fostering a culture of compliance, accountability, and continuous improvement.

Required Skills and Qualifications

Bachelor's degree in Life Sciences, Engineering, Quality, or a related scientific discipline; advanced degree preferred
10+ years of Quality Assurance experience within biotechnology, pharmaceutical, cell therapy, or gene therapy industries, including progressive leadership responsibilities
Demonstrated experience managing enterprise Quality Systems in a regulated GxP environment
Advanced proficiency with eQMS, preferably ZenQMS, including administration, configuration, workflow management, reporting, and user support
Extensive experience developing, revising, implementing, and managing Standard Operating Procedures (SOPs) and controlled quality documentation
Demonstrated expertise managing both GxP and non-GxP training programs, including curriculum development, training assignments, compliance monitoring, and effectiveness assessments.

Preferred Qualifications

Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic products
Strong understanding of FDA, EMA, ICH, and global GxP regulations
Experience leading Quality System implementations, upgrades, or continuous improvement initiatives
Excellent communication, organizational, and project management skills
Proven ability to influence cross-functional stakeholders and lead through change in a fast-paced, growing organization