Senior Director, Regulatory Strategy
Lexeo Therapeutics, New York, NY, United States
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
$244,500 - $290,000 a year
Compensation is dependent on qualifications and experience.
About LEXEO Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.
Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
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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
$244,500 - $290,000 a year
Compensation is dependent on qualifications and experience.
About LEXEO Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.
Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
#J-18808-Ljbffr