Note: The job is a remote job and is open to candidates in USA. Ailux is a biotechnology company developing biologic therapies for immune-mediated diseases. The Clinical Lead will direct global regulatory strategy and execution across therapeutic programs, including regulatory submissions, health authority engagement, development planning, and team leadership.

Responsibilities

• End-to-End Strategy : Define global regulatory pathways from candidate selection, IND/CTA-enabling work, FIH, Phase 1b PoM, Phase 2a PoC, through registration and lifecycle management
• Cross-Functional Alignment : Partner across Research, Clinical, CMC, Safety, and Quality to address evidence gaps and establish stage-appropriate strategies
• Innovative Design : Drive decisions on indications, endpoints, dose, expedited pathways, and adaptive/decentralized trial designs
• Governance : Direct global regulatory teams, establishing clear milestones, risks, and agency commitments for portfolio decisions
• Dossier Ownership : Lead global IND/CTA filings, trial amendments, briefing packages, expedited requests, and marketing applications (MAA/BLA/NDA)
• Agency Engagement : Lead interactions and negotiations with the FDA, EMA, NMPA , and other major authorities, translating feedback into actionable program commitments
• Regulatory Readiness : Translate nonclinical, CMC, clinical, and safety data into robust regulatory positions, ensuring supply and label readiness
• Decision-Quality Evidence : Shape trials to generate robust data on safety, PK/PD, target engagement, and benefit-risk for registration
• Documentation & Compliance : Oversee regulatory aspects of protocols, investigator brochures, study reports, and informed consents
• Lifecycle Pathways : Define post-PoC pathways including pediatric obligations, post-approval commitments, and labeling strategies
• Program Execution : Own global regulatory timelines, sequencing, outsourcing, and budgets aligned with corporate milestones
• Risk Mitigation : Proactively identify scientific, CMC, safety, and regulatory risks, implementing effective contingency plans
• Representation : Act as primary regulatory spokesperson internally to leadership and externally to agencies, partners, and KOLs
• BD & Licensing : Support financing, licensing, and due diligence activities with regulatory feasibility and value assessments
• Capabilities : Build and manage scalable regulatory teams and external vendors (publishers, local agents, consultants)
• Compliance : Embed ICH, GLP/GMP/GCP, data integrity, and inspection-readiness standards across all regulatory operations

Skills

• MD, PhD, PharmD, or equivalent in a relevant scientific field with strong expertise in immunology, inflammation, or rare diseases
• 7–10+ years in Global Regulatory Affairs (biotech/pharma) leading immunology/rare disease programs from preclinical through IND/CTA, FIH, Phase 2 PoC, and beyond
• Deep FDA mastery and strong working knowledge of EMA, NMPA, and ICH frameworks
• Comprehensive understanding across biologics and oral therapeutics (nonclinical, CMC, clinical pharmacology, safety, biomarkers)
• Proven ability to lead agency meetings, negotiate favorable outcomes, leverage expedited pathways, and navigate complex global regulatory landscapes
• Indications in dermatology, rheumatology, gastroenterology, or respiratory diseases
• Experience advancing programs past PoC into global marketing authorizations and commercial launches
• Multi-region submission experience spanning the US, China, Europe, and key global markets
• Development of next-gen biologics (bispecifics, multispecifics) and oral modalities
• Experience scaling biotech regulatory infrastructure and participating in BD/licensing due diligence

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