Careers

Primary Responsibilities

• Manage two or more early and late-stage clinical development programs at LEXEO Therapeutics. 
• Lead a cross-functional development team utilizing project management/planning tools and software to develop program scenarios, integrated program plans, budgets, resource estimates, and study timelines. 
• Leverage drug development expertise with a solid understanding of project strategy, interdependencies, and disease content to help enable strategic discussions and decisions. 
• Proactively develop program goals and manage activities across the program/portfolio to ensure the achievement of deliverables. 
• Perform risk management and facilitate the creation of robust, cross-functional risk mitigation plans. 
• Deliver annual operating plan for the project. 
• Support business development and alliance management activities as required.

Required Skills & Qualifications

• Bachelor's degree in life sciences or related field.
• At least 12 years of experience in drug development and a minimum of 8 years directly in project management.
• Experienced across most phases of drug development executing against the strategy and partnering with early/late-stage clinical development, medical, and commercial teams.
• Therapeutic knowledge of gene therapy research and development.
• Excellent project management skills – drives execution while maintaining the highest quality standards.
• Skilled in the use of MS Office software suite and project planning system(s) to create, manage, and communicate program timelines (e.g., Microsoft Project, Planisware).
• Ability to create data visualizations that provide insights and updates on the status of program and study progress, risk, and development scenarios.
• Highly motivated, self-starter, resourceful, collaborative, with a strong track record of high performance.
• Able to deliver projects in a fast-paced environment.
• Leverage a broad range of leadership skills including situational leadership and the ability to influence without authority.
• Strong communicator with an ability to succinctly summarize various parts of a project effectively and tailor messages to different audiences, including senior leaders.

Preferred Qualifications

• Advanced degree 
• PMP® certification 
• Experience with academic organizations

About Lexeo

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Primary Responsibilities

• Draft or contribute to the development of high-quality submission-ready documents across such as protocols, protocol amendments, clinical study reports, study specific documents (eg, ICFs, narratives), investigational new drug (IND) applications/clinical trial applications (CTAs)/biologics licensing applications (BLA) modules, regulatory designations, Investigator Brochures (IBs), development safety update reports (DSURs), or others documents as needed.  
• Ensure the quality of deliverables by conducting editorial review of documents (grammar, punctuation, consistency) and completing or managing the quality checking of documents according to LEXEO standards.  
• Manage the document development process for deliverables including planning aspects (timeline development, kick-off meetings, communicating scope and accountabilities), project execution (tracking/monitoring progress according to established timelines, conducting team meetings), and project finalization (ensure final agreed content, approval, quality, and compliance). 
• Manage or assist with the oversight of medical writing partners (contract or CRO staff) for writing projects, quality control, and publishing work streams.  
• Interpret complex scientific data and translate into content appropriate for the intended target audience. 
• Apply strategic, critical review principles to documents generated by others. 
• Ensure compliance regarding the use of document templates and following standard operating procedures or working guidelines.  
• Contribute to medical writing process improvement initiatives including the development of Standard Operating Procedures (SOPs) and working guidelines (eg, style guide and writing resource documents).  
• Build and maintain collaborative relationships with cross-functional internal subject matter experts (SMEs) and external partners. 
• Keep informed of new regulations and/or guidance. 

Required Skills & Qualifications

• The ideal candidate will possess a graduate-level education.
• A minimum of 7 to 10 years experience with related work within a pharmaceutical/biotech company or CRO.
• Preference is given to candidates with experience in early to late-phase drug development.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Positive and proactive written and verbal communication skills.
• Direct experience leading the development of protocols and amendments, clinical study reports (CSRs), IBs, and the ability to generate most types of clinical and regulatory medical writing deliverables with minimal oversight.
• Working knowledge of the content and format of the electronic Common Technical Document (eCTD) and document publishing specifications.
• Thorough knowledge of the drug development process and applicable regulatory requirements and guidelines (eg, ICH E3, E6, E9).
• Proficiency in Microsoft Office Suite (including MSProject) and Adobe is required; experience with authoring toolbars, template suites, and reference software is desired.
• Demonstrated high attention to detail in regard to overall document consistency and also to strategic presentation of information in consideration of future deliverables and development plans.
• Ability to adapt and work effectively in changing situations and different program teams. 

About Lexeo

Apply now