Careers

• New York, NY, United States

• Full Time

• Experienced

Job Summary

Reporting to the VP, Clinical Science and Clinical Operations, the Associate Director/Director, Clinical Science is mainly responsible for the scientific and medical input into clinical trials and clinical projects and works hand-in-hand with Clinical Operations on the successful planning and conduct of one or more clinical trials (phase I -III).

The successful candidate will be highly collaborative, motivated and self-directed. The candidate must also possess impeccable communication and organizational skills, a high attention to detail and quality, intellectual curiosity, as well as strong initiative and ability to execute.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

• Preparation of the following documents: protocol and amendments, informed consent forms, clinical submission documents, clinical study reports
• Development of clinical trial designs 
• Presenting aspects of the trial during investigator meetings
• Review of clinical trial data
• Oversight of scientific activities outsourced to a Clinical Research Organization (CRO) 
• Contribute to statistical analysis plans, data listings, (e)CRF, (e)diaries, operations manuals and external provider selection
• Be an active participant in the review of provider specifications (e.g. ECG, central lab), clinical development plans, Investigator’s Brochure (IB) as well as the investigator and country selection
• Perform other duties as required

Required Skills & Qualifications

• MD, PhD, or PharmD with 2+ years industry experience in a position equivalent to Clinical Scientist in drug development
• Gene Therapy, rare disease, and/or neurology experience in biotech company preferred 
• Demonstrated ability to work independently and be a problem solver
• Proven ability to perform key tasks
• Organize work in a structured way with attention to detail and quality
• Ability to work in a matrix and virtual team setting
• Skilled at managing and prioritizing complex tasks
• Excellent written and verbal communication skills
• Collaborative and collegial work style

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

• New York, NY, United States

• Full Time

• Senior Manager/Supervisor

Job Summary

Reporting to the Executive VP and Chief Medical Officer, The Medical Sr/Director will have direct responsibility for advancing high priority clinical programs in all stages of development for the cardiology therapeutic area. S/he will lead the development for one or more programs including both study strategy, protocol development and oversight of CROs and partners.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

• Oversee all clinical aspects of the cardiac gene therapy programs
• Lead the clinical strategy for the cardiac gene therapy programs, working closely with regulatory affairs counterpart
• 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
• 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
• Oversee and mentor cardiac gene therapy clinical scientist(s)
• Perform other duties as required

Required Skills & Qualifications

• MD in cardiology with at least 5 years industry experience in drug development
• Specialization in cardiology and/or industry experience in cardiac drug development 
• Gene Therapy and/or rare disease experience in biotech company preferred 
• Demonstrated ability to work independently and be a problem solver
• Proven ability to lead strategy development
• Organize work in a structured way with attention to detail and quality
• Ability to work in a matrix and virtual team setting
• Skilled at managing and prioritizing complex tasks
• Excellent written and verbal communication skills
• Collaborative and collegial work style

• New York, NY, United States

• Full Time

• Executive

Job Summary

Reporting to the Executive VP and Chief Medical Officer, The Medical Sr/Director will have direct responsibility for advancing high priority clinical programs in all stages of development for the neurology therapeutic area. S/he will lead the development for one or more programs including both study strategy, protocol development and oversight of CROs and partners.

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

• Oversee all clinical aspects of the Neurologic gene therapy programs
• Lead the clinical strategy for the Neurologic gene therapy programs, working closely with Regulatory affairs counterpart
• 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
• 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
• Oversee and mentor neurologic gene therapy Clinical Scientist(s)
• Perform other duties as required

Required Skills & Qualifications

• MD in neurology with at least 5 years industry experience in drug development
• Specialization in neurology and/or industry experience in neurologic drug development
• Gene Therapy and/or rare disease experience in biotech company preferred 
• Demonstrated ability to work independently and be a problem solver
• Proven ability to lead strategy development
• Organize work in a structured way with attention to detail and quality
• Ability to work in a matrix and virtual team setting
• Skilled at managing and prioritizing complex tasks
• Excellent written and verbal communication skills
• Collaborative and collegial work style

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

• New York, NY, United States

• Full Time

• Experienced

Job Summary

Reporting to the Head of Regulatory Affairs, the candidate will act as Regulatory Lead for our cardiac or neurological gene therapy programs work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements.  We are seeking a motivated and ambitious individual to provide leadership and support to regulatory activities to achieve our strategic vision.  In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. 

Location

We are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.

Job Responsibilities

• Contribute to the development and implementation of regulatory strategies to facilitate the progress for assigned programs in all phases of development.
• Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory submissions.
• Actively participate in interactions with regulatory agencies for assigned programs.
• Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global BLAs / MAAs.
• Interact with Regulatory Affairs personnel within external service providers and development partner companies.
• Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
• Perform other duties as required

Required Skills & Qualifications

• Bachelors or advanced degree in a scientific discipline, with a minimum of 4 years’ experience working in a regulated environment, at least 4 years of regulatory experience in the biopharmaceutical industry 
• Experience a plus and experience with rare disease/ orphan drug development and gene therapy desirable.
• Direct experience with pharmaceutical regulatory submissions, managing major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
• Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
• Demonstrated leadership and success in management of regulatory activities and interacting with regulatory agencies, including the FDA.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience is a plus.
• Previous experience in successfully leading assigned activities within cross-functional teams.

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