Vice President, Disease Area Leader-Neuromuscular Disease

Role Summary

The Vice President, Disease Area Leader – Neuromuscular Disease is the strategic and operational leader for late-stage clinical development in the company’s neuro-immunology portfolio. This executive owns the end-to-end development strategy, drives pivotal-stage execution, and ensures programs are positioned for regulatory approval and commercial readiness and launch. This role operates as a senior strategist, manager, and hands-on clinical leader, directly shaping study design, data interpretation, regulatory interactions, and cross-functional alignment. The VP will also be the externally facing voice for the asset to the medical and scientific community.

Responsibilities

• Strategic Leadership
  • Define and lead the late-stage development strategy for neuroimmunology programs, ensuring clear differentiation and regulatory readiness.
  • Drive portfolio prioritization and scenario planning with a pragmatic, resource-conscious approach.
  • Serve as the company’s senior expert in neuro-immunology, integrating emerging science, competitive intelligence, and patient insights.
• Late-Stage Clinical Development
  • Lead design and execution of registration-enabling and planning for post-registrational studies, balancing scientific rigor with operational feasibility.
  • Provide senior medical oversight of clinical team members for ongoing trials, including safety review, data interpretation, and benefit-risk assessments.
  • Partner closely with Clinical Operations to troubleshoot issues, accelerate timelines, and ensure high-quality study conduct across a small, agile team.
  • Oversee development of statistical analysis plans, endpoint strategies, and data packages for regulatory and commercial use.
• Regulatory Strategy & Interactions
  • Contribute to global regulatory strategy for late-stage programs, including preparation of briefing documents, pivotal submissions, and labeling negotiations.
  • Lead clinical interactions with FDA, EMA, and other agencies, ensuring clear, evidence-based communication.
  • Anticipate regulatory risks and proactively develop mitigation strategies.
• Cross-Functional Leadership in a Lean Environment
  • Lead clinical and cross-functional development teams.
  • Partner with Medical Affairs, HEOR, and Commercial to assure KOL engagement and align evidence generation with launch readiness and payer expectations.
  • Collaborate with CMC, Quality, and Manufacturing to ensure late-stage readiness and supply continuity for pivotal studies.
  • Represent the disease area at executive governance forums with crisp, data-driven recommendations.
• External Engagement
  • Build and maintain relationships with key opinion leaders, investigators, and patient advocacy groups in neurology and immunology.
  • Lead advisory boards, scientific congress planning, and publication strategy for late-stage programs.
  • Serve as a senior external representative for the company’s neuro-immunology pipeline.
• Organizational Leadership
  • Mentor and develop a high-performing clinical team including medical and scientific directors.
  • Foster a culture of urgency, scientific excellence, and collaborative problem-solving.
  • Contribute to broader R&D leadership initiatives and capability building.

Qualifications

• MD or MD/PhD with deep experience in neuromuscular disease and neuro-immunology.
• 12–18+ years of industry experience, including leadership of late-stage clinical programs; small-biotech experience strongly preferred.
• Demonstrated success leading Phase 2b/3 or registration-enabling studies.
• Proven track record interacting with global regulatory agencies.
• Strong understanding of neuro-immunology disease biology, patient populations, and evolving therapeutic landscapes.
• Ability to thrive in a fast-paced, resource-lean environment with shifting priorities.
• Exceptional communication and executive-level influence skills.

Skills

• Strategic yet hands-on leader who excels in lean biotech settings.
• Deep neuro-immunology expertise with a pragmatic approach to late-stage execution.
• Decisive, data-driven, and comfortable navigating ambiguity.
• Collaborative executive who builds alignment quickly across small, cross-functional teams.
• Driven by scientific rigor, patient impact, and operational excellence.