The Global Drug Development Program Lead (VP)(autoimmune) is responsible for driving the strategic planning, execution, and delivery of global drug development programs from early clinical phases through regulatory approval and commercialization.  You will lead the design and execution of clinical trials across all phases, ensuring scientific rigor and regulatory compliance. to define development plans, manage clinical operations, and serve as the company’s medical voice in external engagements—including conferences, advisory boards, and regulatory meetings. This role serves as the central point of accountability for program success, ensuring alignment across cross-functional teams and global stakeholders.  This role will have oversight of Pharmacology, Toxicology, Medical Writing and Biometrics.

Key Responsibilities

• Lead the overall development strategy for assigned drug programs, ensuring clear objectives, timelines, and deliverables are established and met.
• Provide scientific leadership across early-stage development through post-marketing activities
• Represent the company in external forums, including scientific conferences and regulatory discussions
• Oversee clinical trial design, execution, and data interpretation
• Lead site selection, patient enrollment, and medical monitoring
• Ensure safety oversight and pharmacovigilance across all clinical programs
• Guide regulatory submission planning and execution, ensuring compliance with global requirements and facilitating interactions with health authorities and partner with regulatory affairs on submissions including INDs, NDAs, BLAs, and CTAs
• Build and mentor a high-performing medical team, fostering a culture of innovation and collaboration
• Collaborate with clinical, regulatory, medical, commercial, manufacturing, and other functional teams to integrate activities and resolve challenges throughout the development lifecycle.
• Develop and maintain comprehensive program plans, including risk assessments, mitigation strategies, and contingency plans to address potential obstacles.
• Serve as the primary contact for internal and external stakeholders, including senior management, global project teams, external partners, and regulatory authorities.
• Provide regular updates to leadership and teams, preparing high-quality presentations, reports, and documentation to support decision-making
• Oversee program budgets, resource allocation, and financial forecasting to ensure efficient use of assets and adherence to organizational priorities.
• Track program progress against milestones, proactively identify issues, and implement corrective actions to maintain momentum and achieve objectives.

Qualifications

• Medical Degree (MD) required; specialization in autoimmune, neurology or neuromuscular.
• Minimum 15 years of experience in pharmaceutical or biotech clinical development
• Proven success leading global clinical programs across Phases 2–3
• Proven track record in global drug development, with significant experience leading cross-functional teams and managing complex projects in the pharmaceutical or biotechnology industry.
• Demonstrated experience with regulatory filings and approvals in the US and internationally
• Extensive knowledge of global regulatory frameworks, including FDA, EMA, CDE, and Good Clinical Practice standards
• Hands-on experience managing direct interactions with regulatory agencies throughout the development lifecycle
• Strong leadership and cross-functional management skills
• Excellent communication and presentation abilities
• Ability to build relationships with KOLs, regulators, and internal stakeholders

Core Competencies

• Collaboration:

Foster a culture of teamwork, transparency, and shared accountability across diverse global teams.

• Innovation:

Champion creative solutions and continuous improvement to accelerate program success.

• Integrity:

Uphold the highest ethical standards in all interactions and decision-making processes.

The salary range for this position is expected to be between $390,000 and $445,000 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.