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About the Role

LEXEO Therapeutics is seeking a Senior Director, Real World Evidence and Health Economics and Outcomes to provide scientific input during protocol development, study design, and oversight of clinical aspects of study conduct. This role involves rigorous assessment of real-world data to evaluate disease natural history and outcomes for LEXEO’s early development and clinical portfolio. The successful candidate will collaborate closely with clinical development and operations teams, and internal stakeholders to achieve milestones, contributing to novel gene therapies in an entrepreneurial environment.

Responsibilities

Lead the development and execution of RWE strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings and dissemination/publication in partnership with Medical Affairs, Regulatory, Clinical Development and relevant internal stakeholders.
Develop and execute natural history of disease assessments for business and early and late development indications.
Plan real world studies to serve as natural history or external controls, or to support clinical studies for regulatory submissions, in collaboration with Regulatory and Clinical Development.
Provide strategic and executional support for cross-functional RWE initiatives including registries, natural history of disease for regulators, payers and clinicians.
Contribute to the creation of clinical development strategic plans, clinical trial designs, electronic case report forms (eCRFs), and statistical analysis plans.
Prepare or oversee vendor preparation of data tables, listings, figures, clinical study reports, and clinical submission documents.
Oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation in close collaboration with the clinical operations team.
Review relevant vendor, CRO and site scopes of work, study budgets, and plans or manuals related to study data, IVRS, central labs, etc., in close collaboration with the clinical operations team.
Develop internal and external training materials and presentations.
Review and analyze interim and final clinical trial data, including summarizing potential safety and efficacy trends, for study documents including CSRs, IBs, and DSURs.
Collaborate closely with clinical development physicians in the strategic planning and conduct of investigator meetings and advisory boards.
Collaborate closely with clinical development physicians in preparing abstracts, manuscripts, presentations, and materials for external meetings related to the protocol and/or clinical program.
Oversee scientific activities outsourced to vendors and clinical research organizations.

Requirements

Relevant clinical or biomedical Ph.D. or relevant Pharmacy, Nursing or MSc/MRes degree.
At least 10 years of drug development and real-world medical research experience within the biopharmaceutical industry; candidates with only academic experience may be considered.
Excellent knowledge of clinical trial design, statistics, and data review tools.
Significant experience in development of protocols and case report forms.
Ability to share scientific data effectively across functions and through presentations.
Significant experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends.
Experience in health economics and outcomes research; payer relevant models.
Working knowledge of ICH and FDA GCP Guidelines.
Experience with clinical studies, research collaborations and real-world data assessments and use.
Experience working in global regulatory and pharmacovigilance environments preferred.
Demonstrated ability to think analytically and strategically, work independently and solve problems.
Publications in peer-reviewed journals for RWE and/or HEOR.
Highly motivated, accountable, self-directed, and able to execute with attention to detail.
Excellent communication and interpersonal relationship skills including negotiating and relationship management skills across multiple functions and with external vendors.
Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style.
Patient-focused with a deep commitment to understanding patient needs.
Gene therapy and/or rare disease experience in a biotech company preferred.
Enjoys being part of a growing team and fast-paced environment.

Skills

Real World Evidence (RWE)
Health Economics and Outcomes Research (HEOR)
Clinical trial design
Protocol development
Data analysis
Scientific communication
Leadership
Collaboration
Problem-solving
Gene therapy
Rare disease research
ICH Guidelines
FDA GCP Guidelines

Location

New York City

Work Type

Hybrid

Experience Level

Senior Director
10+ years of experience

Education Level

Ph.D. in a relevant clinical or biomedical field
MSc/MRes degree in Pharmacy or Nursing

Salary/Compensations

$264,500 - $330,000

About the Company

LEXEO Therapeutics is a clinical-stage genetic medicine company pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases.
Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies.
Backed by a strong financial foundation, LEXEO is positioned to translate groundbreaking science into durable clinical impact.

Equal Opportunity

LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.