[Remote] VP of Clinical Operations

Note: The job is a remote job and is open to candidates in USA. Ailux is a biotechnology company developing therapies for immune-mediated diseases. The VP of Clinical Operations will lead the operational strategy and execution of early-stage global clinical programs, build the Clinical Operations function, and coordinate cross-functional and external partners from preclinical transition through proof of concept and potentially later-stage development.

Responsibilities

• Global Strategy : Define and drive the global clinical operations strategy for early-stage programs (FIH, Phase 1, Phase 1b PoM, Phase 2a PoC) with expansion into later-stage development as programs mature
• Cross-Functional Feasibility : Partner with Clinical Development, Translational Science, Regulatory, and Program Leadership to design scientifically rigorous and operationally feasible early-phase studies
• Innovation & Decision-Making : Champion innovative designs (basket/platform/adaptive trials, DCT elements, digital endpoints) and drive operational decisions around dose, cohorts, site selection, and patient populations for immune-mediated diseases
• Team Leadership : Lead the global Clinical Operations team, setting clear program visions, operational objectives, governance, and decision-making frameworks
• Candidate-to-Clinic Execution : Lead integrated transition planning from candidate selection through IND/CTA clearance and FIH initiation, managing milestones, critical paths, and budgets
• Cross-Functional Alignment : Coordinate across Pharmacology, DMPK, Tox, Safety, Bioanalysis, CMC, Quality, Translational Medicine, and Regulatory to ensure nonclinical and operational readiness
• Supply & Regulatory Readiness : Ensure GMP manufacturing and supply chain logistics; lead operational inputs for IND/CTA filings, vendor governance, safety review plans, and risk mitigation (under GLP/GMP/GCP)
• Trial Delivery : Oversee site activation, recruitment, PI engagement, CRO/vendor management, safety monitoring, and data review to ensure high-quality, compliant trial execution (ICH-GCP)
• Data Integration & Adaptation : Rapidly adapt operational plans (doses, cohorts, indications, endpoints) based on emerging clinical, translational, and safety data
• Late-Stage Hand-Off : Maintain a credible operational pathway from PoC to late-stage development and registration
• Operational Plan Ownership : Own the integrated clinical operational plan, key milestones, dependencies, resource allocations, and budgets in partnership with Project Management
• Risk Governance : Proactively identify scientific, technical, regulatory, and operational risks; establish mitigation plans while balancing pace, quality, patient safety, and compliance
• Strategic Representation : Serve as the primary clinical operations spokesperson internally (presenting operational strategies and investment proposals to senior governance) and externally (collaborators, consultants, BD due diligence)
• Team Development : Mentor a high-performing early-phase clinical operations team, defining clear roles and decision rights in a rapidly expanding pipeline
• Quality & Safety : Embed GMP, ICH-GCP, regulatory, and ethical standards into program execution, ensuring rapid escalation and remediation of safety or quality issues

Skills

• PhD, MD, PharmD , or advanced scientific/medical degree in immunology, inflammation, or a related field
• 7–10+ years of biotech/pharma clinical operations experience, with significant leadership responsibility for global early-phase trials (FIH to Phase 2a PoC)
• Deep end-to-end understanding of drug development (nonclinical, translational medicine, regulatory, CMC, DMPK, clinical PK/PD)
• Strong track record delivering complex early-phase trials, governing CROs/vendors, managing global regulatory filings, and implementing safety oversight
• Strategic thinking, stage-gate governance experience, cross-functional influencing, and ability to thrive in a fast-paced biotech environment
• Background in immunological diseases (dermatology, rheumatology, gastroenterology, respiratory) and therapeutic modalities (biologics, antibodies, multispecifics)
• Proven track record taking a program through PoC into late-stage development
• Direct experience supporting IND/CTA filings with major global health authorities (US, China, Europe)
• Experience with external partnerships, licensing, BD due diligence, or alliance management

Company Overview