Vice President, Disease Area Leader – Neuromuscular Disease

Vice President, Disease Area Leader – Neuromuscular Disease

Reports to:

Chief Medical Officer

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, Disease Area Leader will also be the externally facing voice for the asset to medical and scientific community.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.