Director/Senior Director, Medical Writing

The Director/Senior Director, Medical Writing will lead the Medical Writing function at Lexeo, working cross-functionally to generate and oversee the development of clinical and regulatory documents across all company programs. This role will be responsible for the planning, development, and oversight of study and program level documents with a focus on accuracy, quality, and compliance. Additionally, the role will manage medical writing resources, including vendors and partners, and contribute to process improvement initiatives. 
Hybrid is preferred for this role, but we are open to remote candidates within the US willing to work on Eastern time zone hours.

Primary Responsibilities

• Serve as the Medical Writing Lead for Lexeo’s clinical development programs. 
• Oversee medical writing resource planning, budgeting, and project planning and execution. 
• Draft and direct the writing of company regulatory and clinical documents, including but not limited to Investigator Brochures, IND and CTA Amendments, annual reports, Health Authority briefing documents, clinical trial protocols and amendments, clinical study reports, and summaries. 
• 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 (ensuring final agreed content, approval, quality, and compliance). 
• Oversee regulatory operations and publishing. 
• Ensure the quality of deliverables by conducting editorial review of documents (grammar, punctuation, consistency) and completing or managing the quality checking of documents. 
• Oversee vendor identification, engagement, and management to enable completion of objectives and corporate priorities. 
• Identify and implement organization efficiencies for document development and quality, document management, and submission management. 
• Build and maintain collaborative relationships with medical writing and regulatory partners (contractors, FTE, CROs, and the writing community). 
• Facilitate the development and maintenance of standard processes and style guides. 
• Serve as the StartingPoint Administrator, managing template upgrades, internal user support, and cross-departmental training. 
• Provide oversight for the development of more junior colleagues. 
• Contribute to department initiatives and other duties in support of clinical development as needed. 

Required Skills & Qualifications

• A bachelor's degree is required; a graduate degree (Master's or Ph.D.) is strongly preferred. At least one of these degrees must be in a scientific discipline. 
• Minimum of 8 years experience with at least 4 to 6 years working as a medical writer within a pharmaceutical/biotech company or CRO. 
• 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. 
• 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 (e.g., ICH E3, E6, E9). 
• Advanced writing and speaking competency, positive and proactive written and verbal communication skills. 
• Experience across all phases of clinical development and with most types of regulatory and clinical documents, including highly complex documents. 
• Demonstrated ability to translate complex technical information from mixed sources into written information suitable for an audience of clinicians and health authorities. 
• Demonstrated high attention to detail in overall document consistency and strategic presentation of information. 
• Ability to manage multiple projects simultaneously in a fast-paced environment. 
• Proficiency in Microsoft Office Suite (including MS Project) and Adobe Acrobat as well as authoring toolbars and template suites (Starting Point experience preferred) and reference software. 
• Ability to adapt and work effectively in changing situations and different program teams.

About Lexeo
Lexeo 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