Job Details

Vice President, Disease Area Leader – Neuromuscular Disease

Reports to: Chief Medical Officer

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

Key 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.

Success Profile

· 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.