Careers

Primary Responsibilities

Clinical Trial Execution

Lead day-to-day management of clinical studies to ensure delivery against timelines, budget, and quality expectations

Drive study milestones and proactively identify and mitigate risks 

Vendor & CRO Management

Oversee CROs, laboratories, and vendors to ensure performance aligns with scope, timelines, and budget

Manage vendor relationships, including scope changes, issue resolution, and ongoing performance oversight 

Cross-Functional Collaboration

Partner with internal stakeholders across Clinical, Regulatory, Data Management, and other functions

Serve as a central operational lead to ensure alignment and efficient study execution 

Study Planning & Strategy

Contribute to study planning, including timelines, resource plans, budgets, and risk management strategies

Provide operational input into protocol development, feasibility, and study design 

Site & Study Oversight

Act as the primary sponsor contact for study sites

Oversee site startup and ongoing site management activities

Ensure proper sample handling, data flow, and protocol adherence 

Quality & Compliance

Ensure compliance with ICH/GCP, FDA regulations, and company SOPs

Maintain inspection readiness and support audits and regulatory inspections

Ensure completeness and integrity of the Trial Master File (TMF) 

Documentation & Communication

Author and review study plans, operational documents, and training materials

Communicate study status, risks, and mitigation plans to stakeholders 

Continuous Improvement

Contribute to process improvements and operational excellence initiatives

(Sr. CTM) Lead cross-study or departmental initiatives 

Required Skills and Qualifications

Bachelor’s degree in life sciences or a related field; advanced degree preferred
Clinical Trial Manager: minimum 7 years of clinical research experience; 4 years with advanced degree
Senior Clinical Trial Manager: experience leading complex or global studies, worked on a clinical study from concept to database lock
Strong knowledge of ICH/GCP, FDA regulations, and clinical trial operations
Experience managing CROs and other external vendors
Proven ability to manage timelines, budgets, and multiple priorities
Excellent communication, problem-solving, and leadership skills
Demonstrated leadership skills
Ability to work effectively in a fast-paced, collaborative environment
Ability to travel to sites as needed, including international travel
Ability to work Eastern Time Zone and travel to New York HQ quarterly 

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

Collaborate with Lexeo CMO, R&D leadership, Weill Cornell research staff, Lexeo clinical, quality, and regulatory colleagues, CRO partners and other vendors to conduct clinical trials that meet corporate goals
Evaluate and develop optimal outsourcing model for implementation of trials including selection of CROs and other vendors/ external partners. Oversee development of requests for proposals, negotiate and approve contracts and work orders, and review invoices prior to submission for approval
Develop, maintain, and report on program budgets, including long-range forecasting, in support of Lexeo’s financial goals
Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct
Provide oversight of the CROs to avoid issues or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc. 

Required Skills and Qualifications

Advanced degree preferred and 10+ years of experience in the pharmaceutical or biotech industry within clinical operations and trial management
Experience leading global clinical trials; rare disease/gene therapy trial experience preferred
Thorough knowledge of development program management from IND- through NDA/BLA, including inspection readiness
Extensive experience in CRO/ vendor selection and oversight, budget projection and management, establishing clear milestones, ensuring high-quality data delivery and report generation
Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA
Experience working in a fast-paced environment
Excellent communication skills and ability to influence across multiple functions 

Primary Responsibilities

Manage the day‑to‑day relationship and performance of the MSP to ensure delivery of high‑quality, cost‑effective IT services
Coordinate IT equipment provisioning and maintenance for employees and contractors, including laptops, printers, and communication tools
Ensure effective IT service desk operations, user lifecycle workflows, and asset and license management
Provide direct technical support as needed to employees and consultants across the organization
Deliver IT and cybersecurity training and communicate updates, best practices, and process improvements
Perform regular account and access audits and ensure enforcement of least‑privilege principles
Manage monitoring, maintenance, and support of security tools, systems, and service provider relationships
Support development and continuous improvement of documentation, procedures, and the information security program
Partner with cross‑functional teams to identify opportunities for automation, optimization, and efficiency
Stay current on emerging technologies, cybersecurity risks, and industry best practices to make informed recommendations 

Required Skills & Qualifications

At least 6 years of experience in IT operations, including hands‑on leadership in a growing organization
Minimum of 3 years of experience in the biotechnology or pharmaceutical industry
Strong expertise in Microsoft technologies, M365, and PC environments
Solid understanding of cybersecurity principles, data privacy standards, and compliance frameworks
Experience managing IT projects and implementing infrastructure across diverse technologies
Proficiency in systems administration, networking, security tools, databases, storage systems, and communication technologies
Demonstrated ability to optimize support systems and workflows including use of responsible AI capabilities
Strong critical thinking, decision‑making, and prioritization skills
Service‑oriented mindset with excellent interpersonal, verbal, and written communication abilities