- Oversee all clinical development and strategy aspects of the LX1001 clinical program
- Develop relationships with external experts and advisors
- Lead protocol development and drafting of protocols and amendments
- Oversee conduct of clinical trials including start up, execution, and generation/interpretation of efficacy and safety results
- Ensure clinical support of trials as needed; conduct ongoing medical and scientific review of clinical trial data with cross functional team; manage patient safety reports on trial data to safety and clinical boards; provide input into final analyses and interpretation including the development of the study reports, publications and internal/external presentations
- Present clinical strategy and clinical trial data to management and other internal and external venues
- Participate actively in Regulatory agency interactions, contributing to document generation and participating in meetings with Regulatory agencies
- Cultivate and maintain strong working relationships with key opinion leaders, scientific advisors, and other external experts and stakeholders
- Present clinical strategy and clinical trial data to Company management and external stakeholders, including data safety monitoring boards
- Participate actively in preparation of regulatory submissions, briefing documents, safety reports, BLAs/MAAs, and other regulatory correspondence, and personally participate in regulatory agency interactions
- Provide medical expertise to teams where either general medical expertise is required or where specialty medical input is required
- Liaise with Chief Scientific Officer and CSO Team regarding preclinical and nonclinical activities relevant to corporate pipeline and clinical development strategy
- Perform other duties as required
- Board-certified MD with 10+ years of direct clinical experience
- Specialization in Alzheimers Disease and/or industry experience in CNS drug development
- Gene Therapy experience in a biotech company preferred
- Demonstrated ability to think strategically, work independently and be a problem solver
- Highly motivated and 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 stakeholders
- Skilled at leading and motivating teams to prioritize tasks and deliver on deadlines in a highly collaborative and collegial work style
- Patient-focused with a deep commitment to understanding the needs and improving the lives of patients
- Enjoy being part of a growing team and fast-paced environment
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Senior Medical Director, Clinical Development Alzheimers Disease - New York, United States - LEXEO Therapeutics
Description
Role SummaryThe Senior Medical Director will have clinical development responsibility for advancing the Companys Phase 1/2 study of LX1001 for APOE4-associated Alzheimers Disease (AD), including serving as medical monitor for the study. The Senior Medical Director will also be responsible for designing future studies of LX1001, as well as the clinical development strategy for next-generation therapies in the Companys pipeline for APOE4-associated AD. Expertise in Alzheimers Disease and its mechanisms and the ability to evaluate, interpret, and communicate pre-clinical and clinical data are critical aspects of the role.
Location
Our work culture 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. A remote working model may be considered for exceptional candidates.
Primary Responsibilities
Depending on qualifications and overall experience, base salary is likely to be $250,000 - $350,000 per year.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
Senior Medical Director, Clinical Development Alzheimers Disease professionals in New York City
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Femi Ogunseye
Student at New York University
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Henning Langer
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Matthew Cowan
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Maria Paola Santini
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