Role Summary

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 be responsible for establishing rigorous assessment of real world data to assess the natural history of diseases and real world outcomes for LEXEO's early development and clinical portfolio. The Senior Director, Real World Evidence and Health Economics and Outcomes will work closely with other members of the clinical development and operations teams, and relevant internal stakeholders to execute and deliver milestones. The successful candidate will be highly collaborative and motivated, 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 candidate must also possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.

If you enjoy being a part of a growing team and an entrepreneurial environment in which your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you!

Primary 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 which can serve as natural history or external controls, or buttress the clinical studies for regulatory submissions
• Strategic and executional support for cross-functional RWE initiatives including registries, natural history of disease for regulators, payers and clinicians
• Contributes to creation of clinical development strategic plan, clinical trial design, electronic case report forms (eCRFs), and statistical analysis plans
• Preparation (or oversight of vendor preparation) of data table, listings, figures, clinical study reports and clinical submission documents
• Close collaboration with clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation
• Close collaboration with clinical operations team to review relevant vendor, CRO and site scopes of work, study budgets, and plans or manuals related to study data, IVRS, central labs, etc.
• Development of internal and external training materials and presentations
• Review and analysis of interim and final clinical trial data, including summarizing potential safety and efficacy trends, for study documents including CSRs, IBs, and DSURs
• Close collaboration with clinical development physician in strategic planning and conduct of investigator meetings and advisory boards
• Close collaboration with clinical development physician in preparation of abstracts, manuscripts, presentations, and materials for external meetings as related to the protocol and/or clinical program
• Oversight of scientific activities outsourced to vendors and clinical research organizations

Required Skills and Qualifications

• 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 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 biotech company preferred
• Enjoys being part of a growing team and fast-paced environment

$264,500 - $330,000 a year

Compensation is dependent on qualifications and experience.

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