The Clinical Scientist 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 Clinical Scientist will work closely with other clinical development and operations team members to execute and deliver milestones. The successful candidate will be highly collaborative and motivated, with excellent knowledge of clinical trial design, preferably with experience in rare diseases and gene or cell therapy within cardiovascular disease. 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
- 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 protocols and ancillary study documents, case report forms, operations manuals, investigator's brochures, and operations manuals in collaboration with Clinical Operations Director
- 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 lead in strategic planning and conduct of investigator meetings and advisory boards
- Close collaboration with clinical development lead 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
Qualifications
- Relevant clinical (MD) or biomedical Ph.D. preferable
- At least 5-10 years of drug development or 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
- Excellent knowledge of ICH and FDA GCP Guidelines
- Experience working in global regulatory and pharmacovigilance environments preferred
- Demonstrated ability to think analytically and strategically, work independently, and solve problems
- 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
- Enjoy being part of a growing team and fast-paced environment
$176,000 - $193,000 a yearBase salary dependent on qualifications and overall experience.
About LexeoLexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer's disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March announced a PIPE raising an additional $95M, extending the Company's runway into 2027.Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.