Senior Director, Clinical Development

Lexeo Therapeutics

Clinical development leader advancing late-stage programs at Lexeo Therapeutics targeting cardiac genetic diseases. Providing strategic and hands-on leadership across clinical strategy and cross-functional integration.

Posted 5/15/2026full-timeNew York City • New York • 🇺🇸 United StatesSenior💰 $275,000 - $348,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide clinical development leadership for assigned programs, including late-stage (Phase 2/3 and/or registrational) studies in rare disease and gene therapy.
Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing, and Clinical Operations to shape an integrated development plan aligned with program objectives and BLA strategy.
Lead clinical strategy and oversight of protocol development, endpoint selection, eligibility criteria, safety monitoring approach, and clinical rationale to support health authority interactions.
Serve as a clinical leader for investigator and external expert engagement, including KOL interactions, advisory boards (as applicable), and site relationships to support enrollment and high-quality study conduct.
Drive cross-functional issue resolution and risk management for study execution; ensure decisions are documented and aligned with quality standards and inspection readiness.
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs).
Lead and/or mentor team members through matrix leadership; support a culture of accountability, collaboration, and scientific rigor.

Requirements

What you’ll need

PhD, PharmD, or MD with 5 - 6 years of progressive experience in the biotechnology or pharmaceutical industry within clinical development and late-stage trial delivery.
Proven experience leading late-stage (Phase 2/3 and/or registrational) development for rare disease programs.
Demonstrated experience supporting regulatory submission readiness, including BLA filing activities (e.g., clinical deliverables coordination, inspection readiness support, and cross-functional alignment).
Thorough knowledge of development program management from IND through NDA/BLA, including audit/inspection readiness.
Experience partnering with Clinical Operations and CROs/vendors to deliver high-quality data and documentation, including milestone management, budget awareness, and reporting/CSR support.
Advanced working knowledge of relevant guidelines and regulations (including ICH, GCP, and FDA requirements).
Ability to operate effectively in a fast-paced environment with shifting priorities and timelines.
Excellent communication skills and demonstrated ability to influence across multiple functions and levels, internally and externally.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Lexeo Therapeutics Website LinkedIn All Job Openings 11 - 50 employees 💰 Corporate Round on 2023-08 Based in New York City, Lexeo Therapeutics is a clinical-stage genetic medicines company dedicated to transforming healthcare by applying pioneering science to fundamentally change how disease is treated. Building on groundbreaking research from Weill Cornell Medicine and the University of California San Diego, Lexeo partners with preeminent institutions on the cutting edge of gene therapy research. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4 associated Alzheimer's disease programs, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization. Senior Director, Clinical Development 🔥 5 minutes ago 🏢🏡 New York City – Hybrid 💵 $275k - $348k / year ⏰ Full Time 🟠 Senior 👔 Director 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Provide clinical development leadership for assigned programs, including late-stage (Phase 2/3 and/or registrational) studies in rare disease and gene therapy.
Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing, and Clinical Operations to shape an integrated development plan aligned with program objectives and BLA strategy.
Lead clinical strategy and oversight of protocol development, endpoint selection, eligibility criteria, safety monitoring approach, and clinical rationale to support health authority interactions.
Serve as a clinical leader for investigator and external expert engagement, including KOL interactions, advisory boards (as applicable), and site relationships to support enrollment and high-quality study conduct.
Drive cross-functional issue resolution and risk management for study execution; ensure decisions are documented and aligned with quality standards and inspection readiness.
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs).
Lead and/or mentor team members through matrix leadership; support a culture of accountability, collaboration, and scientific rigor. 🎯 Requirements
PhD, PharmD, or MD with 5 - 6 years of progressive experience in the biotechnology or pharmaceutical industry within clinical development and late-stage trial delivery.
Proven experience leading late-stage (Phase 2/3 and/or registrational) development for rare disease programs.
Demonstrated experience supporting regulatory submission readiness, including BLA filing activities (e.g., clinical deliverables coordination, inspection readiness support, and cross-functional alignment).
Thorough knowledge of development program management from IND through NDA/BLA, including audit/inspection readiness.
Experience partnering with Clinical Operations and CROs/vendors to deliver high-quality data and documentation, including milestone management, budget awareness, and reporting/CSR support.
Advanced working knowledge of relevant guidelines and regulations (including ICH, GCP, and FDA requirements).
Ability to operate effectively in a fast-paced environment with shifting priorities and timelines.
Excellent communication skills and demonstrated ability to influence across multiple functions and levels, internally and externally. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Director, Cyber & Tech E&O Product Line Leader 🔥 1 hour ago Markel 1001 - 5000 💸 Finance 🤝 B2B Website LinkedIn All Job Openings Director leading the strategic vision and plan of Cyber and Tech E&O product lines at Markel. Overseeing product profitability and directing underwriting teams with a focus on growth and retention. 🏢🏡 New York City – Hybrid 💵 $162.8k - $223.8k / year ⏰ Full Time 🟠 Senior 👔 Director 🦅 H1B Visa Sponsor Associate Director – Organizational Effectiveness 🔥 13 hours ago S&P Global 10,000+ employees 💸 Finance 🏢 Enterprise 🤖 Artificial Intelligence Website LinkedIn All Job Openings Consultant designing organizational solutions within S&P Global to enhance performance. Focusing on change management, organizational design, and job work redesign. 🏢🏡 New York City – Hybrid 💵 $104.4k - $170k / year ⏰ Full Time 🟠 Senior 👔 Director Senior Director, Investor Relations 🕒 Yesterday Broadridge 10,000+ employees 💸 Finance 💳 Fintech 🤝 B2B Website LinkedIn All Job Openings Senior Director managing Investor Relations and Corporate Finance functions for Broadridge Financial Solutions. Responsible for strategic messaging and financial analysis for investor engagement. 🏢🏡 New York City – Hybrid 💵 $165k - $210k / year 💰 Post-IPO Debt on 2023-08 ⏰ Full Time 🟠 Senior 👔 Director 🦅 H1B Visa Sponsor Senior Director, Industry Engagement – Platforms 🕒 2 days ago Brookaire Company 51 - 200 🛒 Retail 🚗 Transport Website LinkedIn All Job Openings Senior Director driving global engagement strategy for CFA Institute across investment communities and stakeholders. Building partnerships and platforms for professional collaborations and research influence. 🏢🏡 New York City – Hybrid 💵 $170k - $210k / year ⏰ Full Time 🟠 Senior 👔 Director Senior Complex Director, Excess 🕒 2 days ago AIG 10,000+ employees 💸 Finance 🤝 B2B Website LinkedIn All Job Openings Senior Complex Director overseeing large and complex casualty claims in the insurance sector. Driving investigations, litigation strategies, and client negotiations for high-value claims. 🏢🏡 New York City – Hybrid 💵 $118k - $173k / year ⏰ Full Time 🟠 Senior 👔 Director 🦅 H1B Visa Sponsor View More Director Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical developmentprotocol developmentendpoint selectionsafety monitoringBLA filingIND managementNDA managementaudit readinessmilestone managementregulatory submission readiness

Soft Skills

leadershipcollaborationaccountabilitycommunicationinfluencerisk managementproblem-solvingmentoringcross-functional teamworkadaptability

Certifications

PhDPharmDMD