Careers

Primary Responsibilities

Designs and aligns operational plans to study and company objectives; balances short-term needs with long-term goals
Provide overall management of day-to-day operations of assigned study (ies) to ensure completion per established program goals
Lead cross-functional teams (pre-clinical development, clinical pharmacology, safety, regulatory affairs, clinical supply, biometrics, legal, and medical affairs) and ensure vendors (e.g., CROs, labs, etc,) are compliant with contracted scope of work
Establish the clinical trial budget and collaborate with CRO(s) and finance colleagues to forecast and track the financial status of the program against approved budget
Perform ongoing vendor management and oversight during the study, including review of performed work against budget, negotiation of scope of work, budget amendments, performance management and issue resolution in close collaboration with the Head of Clinical Operations and Project and Portfolio organization
Ensure rigor and availability of documentation to demonstrate sufficiency of sponsor oversight
Review and contribute to operational plans including risk-based approaches to site monitoring, fit for purpose strategies for patient recruitment and retention, patient diversification targets, vendor and site reporting requirements, risk identification and mitigation strategies, trial budgets, site selection, and clinical supplies management
Provide operational input for operational risk assessments, including patient and site burden, diversity considerations during the protocol development process and database design
Contribute to the initial development of the study timelines, deployment of allocated resources, budget, risk and quality plans, escalate issues that may jeopardize time, cost, and the quality of study deliverables
Lead the preparation of vendor requirements, including the definition of project scope, confirmation of vendor qualification, and subsequent selection of key partners. Be responsible for the study team health, including collaborative partners. Oversee feasibility assessments with input from Clinical Development Lead and other relevant cross-functional partners towards the optimal selection of countries and clinical sites
Ensure inspection readiness at all times
Author, audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; ensure other documents and manuals (pharmacy, laboratory, and operations manuals/plans) are sufficiently clear and available for study initiation and execution
Work closely with study sites/vendors to ensure timely and appropriate processes for obtaining, and shipping of sample viability for analysis and data generation
Monitor and communicate with the CRO to ensure data currency i.e., cleaned and coded appropriately to meet all program milestones 
Leverage digital and analytics solutions to generate operational insights through use of study dashboards/metrics, innovative AI-enabled approaches/tools and data to solve execution hurdles, including with vendors (e.g., ICD codes and prescription/script data), to support patient identification and recruitment strategies; contribute to implementation of digital recruitment platforms and decentralized/hybrid trial approaches, as appropriate
Ensure appropriate reporting, documentation, completion, and finalization of any corrective and preventive action plans resulting from audits and inspections
If required, coordinate/provide input to Regulatory Affairs for responses to study questions or issues from Health Authorities
Coordinate responses to study-related questions or issues from IRBs/IECs
Accountable for the overall integrity of the TMF for each respective trial
Ensure study adherence to ICH/GCP/FDA regulations and SOPs
Function as a lead on LEXEO’s Clinical Operation initiatives
Other clinical operation activities that are delegated by Clinical Operations Leadership

Required Skills and Qualifications

Advanced degree (MS/PhD, PharmD) in life sciences preferred with a minimum of 6 years clinical trial management experience. Biotech industry experience preferred. 
Strong knowledge of ICH/GCP/FDA regulations, site monitoring/CRA experience is required
Proven clinical study management skills, and experience of the operational aspects of all stages of clinical studies, including the development of timelines and budgets. Preferably working in a global environment, working with vendors and/or CROs, drug supply management and planning operational activities 
Experience with complex/rigorous study designs 
Well-developed written and verbal communication skills demonstrated by ability to present clear instruction/direction. 
Excellent written and verbal communications skills 
Analytical and problem-solving capabilities 
Experience leveraging digital solutions for operational problem solving and insights (e.g., dashboards and study metrics, analytics, and AI-enabled tools), including partnering with vendors to remove execution hurdles, and using data (e.g., ICD code and prescription/script data) to support patient targeting, digital recruitment, and decentralized/hybrid clinical trial execution
Collaborative and collegial work style  
Attention to detail and follow-up 
Ability to travel to domestic and/or international sites as needed 
Ability to travel to New York City HQ as needed 

Primary Responsibilities

Author statistical analysis plans in conjunction with the clinical team
Responsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programs.
Where applicable, oversees and directs statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with own team, other Biostatistics team members, CROs, and cross-functional partners. Ensures appropriate statistical consultation on trial design and study endpoints and timely and well-executed authoring of statistical analysis plans.
Align the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reports.
Where applicable, oversees, and contributes to completion of all technical and operational statistical activities for a portfolio of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for disease or therapeutic area products of considerable complexity.
Contribute to clinical study designs and clinical development planning for the portfolio.
Where applicable, advises or otherwise ensures timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
Ensures timely and appropriate gathering, organization, and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for clinical studies.
Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
Typically takes a lead in special projects that can benefit multiple biostatistics team members, such as new methodologies, processes, technology and other tools, and may also lead the development and / or implementation of SOPs and related documentation.
Provide statistical leadership in clinical study team setting.
May independently present at department, project team, or Sr. Management meetings.
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and LEXEO’s SOPs. 

Required Skills and Qualifications

• PhD in biostatistics or related discipline with 8+ years (10+ years with MS) relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment 
• Extensive biomedical statistical analysis experience and experience working with relevant software.
• Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics.
• Demonstrated excellence in complex project management and effectively managing multiple projects and priorities.
• Experience working with CROs for data and programming deliverables.
• Experience leveraging AI and machine learning to enhance clinical trial design, analyses and decision-making is preferred.
• Expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects.
• Extensive knowledge of statistical designs, applicable to clinical trials in rare disease which allow for robust study results in smaller datasets.
• Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
• In-depth understanding of the cross-functional roles and responsibilities involved in drug development.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Strong communication and organizational skills.
• Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees.
• Ability to handle multiple development programs simultaneously.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction.
• Analytical and problem-solving capabilities.
• Collaborative and collegial work style.
• Attention to detail and follow-up.

Primary Responsibilities

• Own the coordination and execution of all clinical supply-related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for clinical programs 
• Support IWRS User specifications and UATs 
• Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs 
• Manage supplier relationships with vendors   including maintaining key performance metrics and budget/invoice tracking, review supply needs for study start-up, ongoing resupply strategies, contract negotiation, amendments and closeout requirements 
• Evaluate vendor selection to support clinical study supply chain according to capability and fit 
• Generate RFPs for vendor proposals with the ability to breakdown study protocols to support the supply strategy and communicate study needs to obtain vendor based budgeting or internal support 
• Contribute program budget review and invoicing considerations as it relates clinical supply chain study management and capture any impacts 
• Support the clinical program’s global supply chain in current and future clinical studies for clinical supply to commercial strategy.  Oversee international depots and distribution as appropriate 
• Support governance committees for global clinical operations and global clinical supply chain 
• Ensure consistency across processes and develop tools to implement sustainable improvements 
• Manage the execution of clinical supply strategy for specific clinical programs from early to late stage development with an understanding of commercial launch readiness 
• Understand the roles and responsibilities of all functions represented on cross functional drug development teams to mitigate up and downstream operational deliverables. 
• Support regulatory filings including IND and BLA submission information as it relates to a global supply chain 
• Provide regular updates to the TMF as per departmental requirements that comply with all regulatory requirements. 
• Participate in clinical study team meetings, align with study details, collaborate in meeting study objectives, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development) 
• Additional responsibilities as needed 

Required Skills and Qualifications

• Bachelor's degree in life sciences, business-related field, or supply chain management; Master’s degree in Supply Chain Management preferred 
• Minimum 5 years of experience handling/leading clinical supply chain and logistics; development experience preferred; 10+ years experience (7 years experience with Master’s degree) for Associate Director level 
• Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management strongly preferred 
• Knowledge of clinical materials production processes and design strategy for patient dose kits supporting a clinical study design 
• Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams 
• Demonstrated ability to work in a highly matrixed environment and manage supply chain initiatives in a high performing team across all levels 
• Experience in multi-functional areas (Clinical Operations, Medical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP 
• Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment 
• Extensive experience in planning and execution of investigational materials supply strategies 
• General knowledge of GxP principles is required 

Primary Responsibilities

• Execute and oversee the SEC reporting and accounting close processes (monthly/quarterly/annual), including preparing and reviewing journal entries and balance sheet reconciliations, as well as preparing full quarterly (Form 10-Q) and annual (Form 10-K) financial statements and notes to be filed with the SEC in an accurate and timely manner in accordance with US GAAP 

• Ensure the consistent application, testing and documentation of internal controls in accordance with Sarbanes-Oxley requirements and in compliance with established policies and procedures 

• Lead and mentor two direct reports including the Accounts Payable Manager and the Senior Accountant 

• Ensure accurate expense recognition for accounting close, including R&D and clinical trial accruals, as well as stock-based compensation 

• Review purchase orders and invoices in the intake-to-pay system in close coordination with the Procurement and Accounts Payable functions and T&E reports in the expense reporting system for accuracy, validity and compliance with established policies and procedures 

• Manage accounts payable operations and activities, as well as the cash management and treasury functions including accounting for the Company’s investments in US Treasury securities 

• Effect other SEC filings as needed (Form 8-K, Form DEF 14A, Registration Statement on Form S-8, etc.) 

• Prepare and file local quarterly and annual tax returns including New York Sales and Use Tax and New York City Commercial Rent Tax 

• Partner with and serve as the main contact for external auditors regarding quarterly reviews and annual audits 

• Work closely with the Company’s Payroll and Equity Administration, Human Resource, and Legal functions to maintain accurate payroll and equity records 

• Coordinate with internal stakeholders regarding costs and activities incurred on various contracts; prepare ad hoc analyses as requested 

• Manage the Accounting department budgeting process and coordinate with FP&A as needed on the company-wide budget to actual process 

• Maintain working relationships across the Company’s R&D and G&A teams 

• Seek out opportunities for continuous improvement in the Accounting function, including the application of new software and Artificial Intelligence 

• Other duties as assigned  

Required Skills and Qualifications

• Bachelor’s degree in Accounting or related field; CPA preferred 

• 10+ years of progressive accounting experience in the biotechnology industry (8+ years with a Graduate degree) 

• Public accounting experience at a Big 4 firm preferred 

• Robust understanding of and experience with:

(i) SEC reporting including financial statement preparation and disclosures, Sarbanes-Oxley internal controls compliance, and monthly/quarterly/annual accounting close processes;

(ii) US GAAP including accrual-based accounting and accounting for stock-based compensation (preferably at a public biotech company); 

(iii) ERP and intake-to-pay systems (preferably NetSuite and Zip) 

• Advanced Excel skills (modeling, pivot tables, VLOOKUPs) 

• Prior experience mentoring and leading teams 

• Proven ability to work independently while influencing others 

• Experience operating in an ever-changing environment 

Primary Responsibilities

Manage the day‑to‑day relationship and performance of the MSP to ensure delivery of high‑quality, cost‑effective IT services
Coordinate IT equipment provisioning and maintenance for employees and contractors, including laptops, printers, and communication tools
Ensure effective IT service desk operations, user lifecycle workflows, and asset and license management
Provide direct technical support as needed to employees and consultants across the organization
Deliver IT and cybersecurity training and communicate updates, best practices, and process improvements
Perform regular account and access audits and ensure enforcement of least‑privilege principles
Manage monitoring, maintenance, and support of security tools, systems, and service provider relationships
Support development and continuous improvement of documentation, procedures, and the information security program
Partner with cross‑functional teams to identify opportunities for automation, optimization, and efficiency
Stay current on emerging technologies, cybersecurity risks, and industry best practices to make informed recommendations 

Required Skills & Qualifications

At least 6 years of experience in IT operations, including hands‑on leadership in a growing organization
Minimum of 3 years of experience in the biotechnology or pharmaceutical industry
Strong expertise in Microsoft technologies, M365, and PC environments
Solid understanding of cybersecurity principles, data privacy standards, and compliance frameworks
Experience managing IT projects and implementing infrastructure across diverse technologies
Proficiency in systems administration, networking, security tools, databases, storage systems, and communication technologies
Demonstrated ability to optimize support systems and workflows including use of responsible AI capabilities
Strong critical thinking, decision‑making, and prioritization skills
Service‑oriented mindset with excellent interpersonal, verbal, and written communication abilities 

Key Responsibilities

AI/ML Strategy + Delivery  

Define and execute Lexeo’s applied AI/ML roadmap across discovery and development, prioritizing use cases that improve speed, quality, and decision confidence. 

Deliver solutions that are internal-only (e.g., scientific decision support, operational forecasting) and those that are generated internally but external-facing (e.g., partner-ready analyses (regulatory dossiers, briefing books, protocols etc.), validated dashboards, and decision materials).

Establish best practices for model lifecycle management (validation, documentation, monitoring, retraining), especially where outputs influence scientific decisions or regulated workflows. 

Advanced Analytics + Predictive Modeling 

Lead development and selection of appropriate ML approaches (e.g., XGBoost, Random Forest, SVMs, and other advanced models) based on problem framing, data constraints, interpretability needs, and deployment context.

Build and oversee predictive analytics using real-world data, including robust evaluation design, bias/variance trade-offs, and performance monitoring. 

Small Data Excellence + Synthetic Controls  

Apply techniques to amplify signal-to-noise in smaller datasets (e.g., regularization, Bayesian methods, hierarchical modeling, augmentation, multimodal integration, careful feature engineering, uncertainty quantification).

Guide strategy for synthetic control arms and comparable approaches (as appropriate), ensuring methodological rigor, transparency, and fit-for-purpose use in decision-making. 

Drug Discovery / Translational Partnership 

Translate drug discovery and translational questions into testable analytical hypotheses; partner with bench scientists to design data capture that enables strong modeling.

Serve as a bridge between scientific teams and data/engineering, ensuring solutions are scientifically credible and operationally adoptable. 

Cross-functional Enablement + Platform Integration 

Partner with stakeholders across R&D, CMC, Clinical, Safety, and IT/Security to implement scalable data pipelines and AI-enabled workflows.

Contribute leadership to current and emerging initiatives such as AI workflow automation/database buildouts and analytics agents that leverage enterprise platforms (examples already in motion include CMC AI automation, MaxisAI clinical database/AI efforts, and AI work to ingest historical data into Dataverse/Fabric for agent-based analysis; integration work such as a Benchling AI API initiative may also be in scope depending on priorities). 

External Partner/Vendor Leadership 

Liaise with external partners to evaluate tools, define statements of work, and deliver solutions—while ensuring knowledge transfer and sustainable internal ownership.  

Operational Excellence 

Improve internal processes through automation and analytics, focusing on measurable impact (cycle time, error reduction, throughput, decision latency).

Establish practical governance for data quality, documentation, and fit-for-use standards aligned with the realities of biopharma environments (including where regulated practices apply). 

What Success Looks like (First 6-12 Months)

A prioritized AI/analytics roadmap tied to measurable R&D outcomes; clear ownership and delivery cadence.

2–4 production-grade analytics solutions adopted by teams (internal and/or external-facing outputs as needed).

A repeatable approach for small datasets and high-noise signals; documented modeling standards and review practices.

Strong partner engagement model: vendors/partners used strategically, with internal capability building and durable outcomes. 

 

Required Qualifications

Advanced degree in a quantitative or scientific discipline (PhD strongly preferred; MS with exceptional experience considered).
10+ years of relevant experience across applied data science/ML in life sciences/biopharma (or adjacent domain with direct drug discovery translation), including 5+ years leading teams and influencing senior stakeholders.
Deep familiarity with advanced ML methods (including XGBoost, Random Forest, SVMs) and the judgment to select and justify the right tool for the job.
Demonstrated experience building predictive models with real-world, imperfect datasets and delivering them into production or decision workflows.
Proven ability to improve processes and operationalize analytics—moving beyond prototypes to adoption.
Strong cross-functional communication: can partner with scientists, engineers, and executives; can explain model performance and limitations clearly. 

Preferred Qualifications

Direct experience in drug discovery, translational research, and/or R&D decision support (target ID/validation, MoA, biomarker strategy, preclinical data integration).
Experience with small data strategies, causality-aware thinking, and synthetic control arms or closely related methodologies.
Experience operating in regulated/quality-sensitive environments and building documentation practices that scale (particularly relevant where validation and traceability are required).
Familiarity with enterprise data platforms and modern analytics stacks (lakehouse/warehouse patterns, feature stores, MLOps, model monitoring).

Primary Responsibilities

• Design and execute proof-of-concept genetic medicine studies in cell lines, primary cells, iPSC-derived cells and animal models 
• Design and oversee in vitro and in vivo pre-clinical studies to evaluate the efficacy and safety of genetic medicine strategies with CROs and external partners 
• Develop and execute assays for in vitro and in vivo phenotypic outcomes using next-generation sequencing (NGS), PCR, qPCR, flow cytometry, Western blots and/or ELISA 
• Analyze and interpret data and present to internal and external audiences 
• Contribute to the scientific efforts and develop innovative solutions by maintaining a broad understanding of the field 

Required Skills and Qualifications

• PhD degree (in life sciences or related discipline) and at least 2 years of industry or postdoc experience or MS degree with at least 4 years of relevant experience in industry or academia 
• Extensive experience with mammalian cell culture including primary human cells is required, culturing of iPSCs and iPSC-derived cardiomyocytes is a plus 
• Technical experience in genomics and molecular and cellular biology (NGS, PCR, qPCR, flow cytometry, Western blots, ELISA) 
• Familiarity with drug discovery for genetic medicines  
• Ability to multi-task and excel in a fast-paced environment 
• Excellent troubleshooting, written/verbal communication and project management skills 
• Proficiency with applications used for scientific data analysis (e.g., GraphPad, MS, JMP, etc)

Primary Responsibilities

Draft and contribute to the development of high-quality submission-ready documents such as protocols, protocol amendments, clinical study reports, investigational new drug applications (INDs)/clinical trial applications (CTAs)/biologics license applications (BLAs) modules, regulatory designations, lifecycle maintenance documents, briefing documents, or others as needed. 
Ensure the quality of deliverables by conducting editorial reviews 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 (ensuring final agreed content, approval, quality, and compliance).
Publish documents for submission and/or oversee Regulatory Operations vendors as needed and review published documents prior to submission. Use AI and automation to support publishing activities such as document formatting, hyperlinking, and validation checks. Ensure final submission packages (e.g., eCTD sequences) are complete, correctly formatted, and pass technical quality standards. Collaborate with Regulatory Operations to troubleshoot any document formatting or technical issues, leveraging AI tools for efficiency where possible.
Use AI capabilities and implement new AI of appropriate scope to improve efficiencies and optimize processes of all activities related to Regulatory and Medical Writing.
AI Tools Evaluation & Implementation: Research, evaluate, and implement AI-powered tools to enhance the regulatory, medical writing, and publishing process. Identify appropriate AI solutions (e.g., for text generation, summarization, consistency checks, or document formatting) that fit the organization’s scale and needs. Lead pilot projects to test these tools and measure their impact on efficiency and quality.
AI-Driven Process Optimization: Drive the integration of AI technologies into daily medical writing activities to automate or streamline routine tasks. For example, deploy AI assistance for initial draft generation of certain sections, automatic formatting or indexing for eCTD submissions, content comparison for consistency across documents, and automated quality checks for style and reference accuracy. Ensure that such implementations adhere to regulatory guidelines and data privacy requirements while delivering efficiency gains.  
Training and Change Management: Act as the lead for training the medical writing (and regulatory and clinical development as appropriate) team(s) on new AI/digital tools and updated workflows. Develop user guidelines or job aids and conduct hands-on training sessions to help writers and reviewers effectively use AI tools (e.g., AI content generators or QC software). Provide ongoing support and champion user adoption to maximize the tools’ benefits, while also gathering feedback to refine tool use-cases. 
Process Improvement & Innovation: Continuously monitor emerging trends and best practices in medical writing and AI. Propose and lead process improvement initiatives that enhance document quality or team productivity – for example, developing standard content libraries, improving templates, or introducing structured content management approaches in combination with AI. Maintain up-to-date knowledge of regulatory expectations regarding the use of AI in document preparation to ensure responsible implementation.
Oversee vendor identification, engagement, and management to enable completion of objectives and corporate priorities as requested.
Identify and implement organizational efficiencies for document development and quality, document management, and submission management.
Facilitate the development and maintenance of standard processes and style guides.
Serve as a StartingPoint Administrator, managing template upgrades, internal user support, and cross-departmental training.
Contribute to department initiatives and other duties in support of clinical development as needed, including in the development of AI tools and technology. This may include determining appropriate vendors and tools, disseminating information to the team, and conducting training on new AI technologies.  

Required Skills and 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.
Understanding of, and experience using, AI tools available to aid in medical writing with direct experience implementing AI tools in a Regulatory/Medical Writing/Clinical Development setting strongly preferred.
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 Copilot) and Adobe Acrobat as well as authoring toolbars and template suites (Starting Point experience preferred) and reference software (Endnote).
Ability to adapt and work effectively in changing situations and different program teams.
Keep informed of new regulations and guidance.
Ability to work Eastern Time Zone
Ability to travel to NY HQ as needed.

Role Summary 

The Senior Director, Regulatory Strategy will provide global regulatory leadership for AAV gene therapy development programs with an emphasis on early-stage clinical development. This role is responsible for defining and executing integrated regulatory strategies that align with corporate objectives, development timelines, and evolving global regulatory expectations for gene therapy products. 

The ideal candidate will have deep experience leading global regulatory programs and extensive interaction with FDA, EMA, and other major health authorities. Strong preference will be given to candidates who also have regulatory CMC experience that could fill a dual role leading regulatory CMC. 

Primary Responsibilities

Function as the global regulatory lead for early stage programs and participate in and advise global development teams  

Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2) 

Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies 

Lead the strategy and preparation of key regulatory objectives and documents such as Fast Track, RMAT, PRIME, and health authority meetings (INTERACT, Pre-IND, PDUFA meetings, scientific advice, etc.). 

Proactively identify and communicate potential risks and define mitigation strategies 

Monitor the evolving regulatory landscape for gene therapy and proactively advise internal stakeholders on global regulatory guidelines and requirements   

Lead and manage the preparation and publication of regulatory submissions 

Oversee regulatory activities conducted by CROs to ensure alignment with overall strategy 

 

Additional Potential Regulatory CMC Responsibilities

Provide regulatory leadership for CMC strategy, particularly for AAV vector manufacturing, analytical control strategies, comparability, and lifecycle changes 
Partner closely with CMC, technical operations, and quality teams to align regulatory expectations with manufacturing realities 
Lead or contribute to regulatory strategies for: 
Process development and scale‑up 
Control strategy evolution 
Manufacturing changes and comparability assessments 
Interpret and apply evolving global guidance related to gene therapy CMC 

Required Skills and Qualifications

Advanced degree in a scientific discipline is strongly preferred 
Minimum 10 years of experience in Regulatory Affairs  
Proven experience with global regulatory submissions (IND/CTA/BLA)  
Direct experience with FDA and EMA meetings and interactions 
Strong leadership experience  
Excellent interpersonal and verbal and written communication skills; strong presentation skills 
Excellent planning and organizational skills 
Ability to travel monthly to NY HQ if not local to the area

Strongly Preferred Qualifications

Regulatory CMC experience, particularly with gene therapy or other biologics 
Familiarity with accelerated pathways (RMAT, PRIME, Breakthrough Therapy) 
Experience in rare disease development  
Prior experience in a biotech or emerging company environment 

Primary Responsibilities

• Lead work plans (SOWs) by working with department leaders, key stakeholders and CROs following the principles of Good Laboratory Practices (GLPs/21 CFR 58), where applicable, and company Standard Operating Procedures (SOPs)
• Coordinate meetings with vendors to ensure agendas are appropriate for the discussion, ensure meeting minutes are documented, follow-up on action items, and provide status updates to the internal teams
• Liaise with bioanalytical leads to ensure 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
• 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
• Summarize key findings of data as well as relevant scientific publications in presentations for internal review
• Work closely with Medical Writing and contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs 
• Coordinate with other internal and external stakeholders, including Clinical, CMC, Regulatory Affairs, and Finance and Accounting teams

Required Skills & Qualifications

• BS with 10+ years, MS with 8+ years or Ph.D. with 4+ years in life sciences, pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences or equivalent 
• Experience in AAV gene therapy products for minimum of 2 years   
• Working knowledge of GLP and ICH guidelines  
• Experience managing studies and authoring non-clinical sections of regulatory documents, particularly pre-INDs and INDs 
• 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, strong interpersonal communication, multi-tasking ability, passion to thrive in challenges, and desire to strive in a fast-paced environment