Careers

• New York, NY, United States

• Full Time

• Experienced

Role Summary

At LEXEO Therapeutics, the Program Manager (PM) provides end-to-end project and planning leadership of LEXEO’s medicines and teams. The PM serves as the operational leader of programs to ensure that the development plan is delivered on schedule, within budget, and with quality through product approval.

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.

Primary Responsibilities

• Manage two or more early 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 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 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 8 years of experience in drug development and a minimum of 4 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.
• Excellent project management skills – drives execution while maintaining the highest quality standards.
• Skilled in 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 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 in addition to above:

• Advance degree
• PMP® certification
• Experience with academic organizations
• Therapeutic knowledge of gene therapy research and development

Depending on qualifications and overall experience, base salary is likely to be $200,000 - $260,000 per year.

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

• New York, NY, United States

• Full Time

• Mid Level

Role Summary

Reporting to the Director, Bioanalytical Development and Quality, this position will support oversight of bioanalytical operations including method development, qualification, validation, and sample analysis for nonclinical studies related to AAV-based gene therapy for cardiac and CNS disorders.

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.

Primary Responsibilities

• Lead bioanalytical work plans (SOWs) by working with department leaders, key stakeholders and CROs in compliance with 21 CFR 58, Good Laboratory Practices (GLPs) and company Standard Operating Procedures (SOPs).
• Coordinate meetings with bioanalytical vendors to ensure agendas are appropriate for the discussion, write meeting minutes, follow-up on action items, and provide status updates to the internal teams.  
• Monitor and evaluate the progress of bioanalytical projects with respect to milestones, budgets and timelines.
• Manage bioanalytical studies to ensure that bioanalysis is well coordinated with in-life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period.
• Manage and coordinate logistics of nonclinical bioanalytical samples, reagents, and supplies, and maintain trackers for various studies and data.
• Monitor the study plan, timelines, and progress of study deliverables against forecasted timelines and budget and escalate issues that impact the study plan or budget in an effective and transparent manner. 
• Work closely with quality assurance to ensure compliance is checked as appropriate.
• Monitor study quality and proactively engage with department leaders to implement solutions for issues that arise.
• Reviewing study plans, SOPs, reports and interpret bioanalytical data.
• Summarize key findings of data as well as relevant scientific publications in presentations for internal review.
• Maintain a broad knowledge of state-of-the-art principles, theory, and application of bioanalytical sciences.
• Coordinate with internal and external stakeholders, including on-clinical, Clinical, CMC, Quality Assurance, and Regulatory Affairs teams.

Required Skills & Qualifications

• BS with 10+ years, MS with 8+ years or Ph.D. with 4+ years in life sciences, pharmaceutical sciences, biochemistry, or equivalent
• Experience in cell and gene therapy products for minimum of 2 years 
• Working knowledge of GLP and ICH guidelines
• Working knowledge of management of studies and projects
• Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity.
• Results oriented, has a bias for action. Strong initiative, accountability, and willingness to take ownership and drive projects to completion.
• Accustomed to “roll up their sleeves” and execute the tasks needed in a small company environment.
• A demonstrated sense of urgency and ability to work independently and under tight deadlines is required.
• This position requires collaborative skills, multi-tasking ability, passion to thrive in challenges, and desire to strive in a fast-paced environment.

Depending on qualifications and overall experience, base salary is likely to be $110,000 - $145,000 per year.

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

• New York, NY, United States

• Full Time

• Manager/Supervisor

Role Summary

The Global Regulatory Lead, Gene Therapy Programs, and International Regulatory Lead is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various early development products across a portfolio of potential gene therapy treatments.

• Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for multiple projects.
• Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Represents LEXEO Therapeutics as applicable in industry/regulatory forums to lead regulatory innovation.

Location

Virtual with occasional travel to LEXEO HQ

Primary Responsibilities

• Will be responsible for multiple complex projects across LEXEO’s gene therapy portfolio.
• Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams.
• Will lead and/or supervise IND/CTA and BLA/MAA submissions activities.
• Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.
• The candidate will be accountable for global Health Authority submissions and approvals.
• Direct point of contact with health authorities, leads and manages Health Authority meetings. Manages direct reports as needed.
• Leads the GRT and proactively solicits input from regulatory regional specialists, other functions and vendors to ensure global regulatory submissions are provided to local LEXEO Therapeutics affiliates in compliance with local regulations and support the project objectives.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
• Serves as lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends and new health authority requirements that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.

Required Skills & Qualifications

• Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD). BA acceptable with significant Industry experience.
• Sr Director 12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ years of regulatory and related experience.
• Gene Therapy experience is strongly preferred. If no direct GTx experience, then strong background in biologics in novel therapeutic modalities required.
• Extensive experience in the US and International Regulatory Affairs, including practical experience with INDs, BLAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
• Has demonstrated submission and approval of an NDA and/or BLA with a major Health Authority.
• Expert technical and regulatory knowledge of the requirements for compliance in GCPs and an in-depth knowledge of global submission requirements, with a strong understanding of the application of ICH and other guidance.

Expectations will include:

• Lead cross functional team in the development of a Label as Driver for respective programs.
• Understands and works effectively with a Global Team to develop the regulatory framework for the clinical development of products in early development leading to global marketing authorizations.
• Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products.

Depending on qualifications and overall experience, base salary is likely to be $220,000 - $270,000 per year

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

• New York, NY, United States

• Full Time

• Mid Level

Role Summary

The Associate Director, Medical Writing, reporting into the Executive Director, Medical Writing and Regulatory Affairs, will work in partnership with cross-functional teams to generate and lead the development of Clinical and Regulatory documents across all LEXEO 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. This role will assist in oversight of external partners and process development initiatives and will be an integral contributor to the completion of department and corporate objectives. To be successful in this position, candidates will possess a commitment to excellence, a patient- and team-focused mindset, knowledge of ICH and health authority guidance, and demonstrated leadership in operational and strategic aspects of document development.

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.

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 4 to 6 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.

Depending on qualifications and overall experience, base salary is likely to be $150,000 - $195,000 per year.

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