Senior Director, Real World Evidence & Health Economics and Outcomes

Role Summary

The Senior Director,Real World Evidenceand Health Economics and Outcomes,is responsible forprovidingscientific inputduring protocol development, study design, oversight of clinical aspects ofstudy conduct, and interpretation of study results through the final study report. The candidate will also be responsible for establishing rigorous assessment ofreal worlddata to assess the natural history of diseases andreal worldoutcomes 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.

T he successful candidate will be highly collaborativeandmotivated, with excellent knowledge offirst-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!

• 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,payersand clinicians
• Contributes to creation of clinicaldevelopmentstrategic plan,clinicaltrialdesign,electronic case report forms (eCRFs),and statistical analysis plans
• Preparation(or oversight of vendor preparation) of datatable,listings,figures,clinical studyreportsandclinical submission documents
• Close collaboration with clinical operations team to overseeprotocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation
• Close collaboration with clinical operations team to reviewrelevantvendor, CRO and site scopesof 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 finalclinical 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

• 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…