VP, Clinical Development

Vice President, Clinical Development - CNS Gene Therapy

Location: Remote | Company: Leading Gene Therapy Biotechnology Company | Focus: Central Nervous System

The Opportunity

Join a pioneering biotechnology company at the forefront of gene therapy innovation. As Vice President of Clinical Development, you'll lead a strategic CNS program as a core member of an Integrated Product Team (IPT), overseeing global clinical development from early phases through regulatory approval and commercial launch.

Reporting to the Head of Global Clinical Development, you'll build and lead a team of medical directors while partnering cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, and other key functions to advance transformative therapies for patients with serious neurological conditions.

Key Responsibilities

Strategic Leadership

• Lead global clinical development strategy for CNS gene therapy program within IPT framework
• Co-chair the Clinical Sub-team (CST) alongside Clinical Operations leadership
• Build, mentor, and manage a team of clinical development physicians
• Drive cross-functional alignment across Program Management, Regulatory, Medical Affairs, Commercial, and CMC

Clinical Development & Execution

• Develop and execute clinical strategies spanning Phase I-IV, designed for regulatory success and commercial viability
• Oversee creation of critical documents: protocols, CDPs, IBs, CSRs, and regulatory submissions
• Lead IND/NDA/BLA submissions and interactions with regulatory authorities (FDA/EMA)
• Identify clinical risks and implement mitigation strategies for complex gene therapy studies

Commercial Readiness

• Partner with Market Access and Commercial teams to maximize product positioning for launch
• Ensure clinical strategies align with Target Product Profile (TPP) for global market access
• Serve as clinical SME in launch preparation activities

External Engagement

• Lead interactions with regulatory authorities, KOLs, Data Monitoring Committees, and patient advocacy groups
• Organize and manage scientific/clinical advisory boards
• Collaborate with Medical Affairs on publications and presentations

Required Qualifications

Clinical Credentials

• MD/DO with Neurology residency (Psychiatry residency also considered)
• 10+ years pharmaceutical/biotech industry experience across Phases I-IV
• Movement disorders fellowship training (preferred)

Critical Industry Experience

• Proven commercial launch experience - must have been at company during/before commercial product launch
• Biologics platform experience required (antibodies, protein therapeutics, etc.)
• Strong NDA/BLA submission track record with regulatory approvals
• Phase 2 and beyond clinical program experience
• Gene therapy development experience (strongly preferred)

Leadership Requirements

• Senior Leadership Team (SLT) experience - must have led other leaders
• Direct line management experience with proven team development track record
• Integrated Product Team (IPT) model experience required
• Demonstrated ability to influence C-suite and cross-functional stakeholders
• Success navigating matrix environments and competing priorities

Technical Expertise

• In-depth knowledge of ICH-GCP, clinical trial design, biostatistics, and global regulatory frameworks
• Experience with CNS-specific endpoints, biomarkers, and drug delivery considerations
• Strong scientific partnership skills with internal/external stakeholders

What Makes You Stand Out

The ideal candidate brings both clinical excellence and commercial acumen - someone who understands not just how to design rigorous trials, but how to position products for market success. You've lived through the full product lifecycle, navigated complex regulatory pathways, and know how to lead without direct authority in IPT environments.

You're the right fit if:

• You were in the room when commercial launch decisions were made
• You can speak fluently to both clinical scientists and business leaders
• You thrive in collaborative, matrixed environments with diverse perspectives
• You've successfully shepherded products through NDA/BLA approval
• You build and develop high-performing teams that deliver results

Compensation and Culture

Competitive package including:

• Base salary commensurate with experience (VP-level range)
• Performance-based bonus structure
• Comprehensive benefits
• Remote work flexibility
• Opportunity to impact patients with serious unmet neurological needs

Company culture emphasizes:

• Cross-functional collaboration and open dialogue
• Scientific rigor with commercial pragmatism
• Patient-focused innovation
• Professional development and mentorship

Next Steps

This is a confidential executive search. The successful candidate will join at a pivotal inflection point, leading a promising CNS gene therapy program toward regulatory milestones and commercial launch.

To express interest or learn more, please contact your recruiting representative at SEC.

Authorization to work in the United States required. Our client is an equal opportunity employer committed to diversity and inclusion.