À propos de ce poste Senior Director, Real World Evidence & Health Economics and Outcomes chez Lexeotx

Lexeotx · Hybride · New York, New York

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

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.

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

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

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À propos de ce poste Senior Director, Real World Evidence & Health Economics and Outcomes chez Lexeotx

Primary Responsibilities

Required Skills and Qualifications

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