Senior Director, Real World Evidence & Health Economics and Outcomes

About the Role

The Senior Director, Real World Evidence and Health Economics and Outcomes, is responsible for providing scientific input during protocol development, study design, oversight of clinical aspects of study conduct, and interpretation of study results through the final study report. The candidate will also establish rigorous assessment of real world data to evaluate the natural history of diseases and real world outcomes for LEXEO’s early development and clinical portfolio.

The successful candidate will work closely with other members of the clinical development and operations teams, and relevant internal stakeholders to execute and deliver milestones. This role requires a highly collaborative and motivated individual with excellent knowledge of first-in-human clinical trial design, preferably with experience in gene or cell therapy, and experience developing RWE historical control and methods.

The ideal candidate must possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and demonstrate strong initiative and execution to timelines. If you enjoy being part of a growing team and an entrepreneurial environment where your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you!

Responsibilities

• Work in partnership with Medical Affairs, Regulatory, Clinical Development, and relevant internal stakeholders to lead the development and execution of RWE strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings, and dissemination/publication.
• Study concept development and execution of natural history of disease assessment for business and early and late development indications.
• Collaborate with Regulatory and Clinical Development to plan real world studies that can serve as natural history or external controls, or support clinical studies for regulatory submissions.
• 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 the clinical development strategic plan, clinical trial design, 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.
• Collaborate closely with the clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation.
• Review relevant vendor, CRO, and site scopes of work, study budgets, and plans or manuals related to study data, IVRS, central labs, etc.
• 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 such as CSRs, IBs, and DSURs.
• Collaborate closely with clinical development physicians in strategic planning and conduct of investigator meetings and advisory boards.
• Prepare 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 exposure to 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 the 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 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.

About LEXEO

LEXEO Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, 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.

Schedule

Our work culture is a hybrid model with 2 days per week in the New York City office and 3 days working from home.