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.
Salary Range
The salary range for the Vice President, Disease Area Lead-Neuromuscular Disease is expected to be between $390,000 and $425,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.