VP of Clinical Operations

The Company
Ailux is an innovative biotechnology company harnessing AI to accelerate breakthrough biologic therapies in difficult immune-mediated diseases and improve the lives of patients with significant unmet medical need. Built on intelligent design and guided by people who care about transforming healthcare, our technology is redefining what is possible in biologics development, from how we select targets to how we engineer the molecules.Ailux’s vision is to light the path to new cures and fundamentally change our approach to science and drug development to redefine current treatment paradigms. We look to continue unlocking the potential of disease biology, integrate AI-enabled biologics development, and deliver effective clinical execution.Backed by an experienced leadership team, leading scientific advisors, a highly multidisciplinary organization, and strategic partnerships in biopharma, Ailux is approaching a key inflection point as its first wave of therapeutic programs advance toward clinical development. This is an opportunity to play a vital role in leading programs from pre-clinical development into the clinic and through clinical proof-of-concept, shaping the pipeline and development culture of a rapidly growing biotechnology company.
Role Overview
The VP of Clinical Operations is accountable for the integrated strategy, leadership, and delivery of operational aspects of early‑stage clinical development for the company’s pipeline of therapies targeting immune‑mediated diseases. This executive will be responsible for planning and executing global IND/CTA/FDA/China-enabling development first‑in‑human (FIH), Phase 1, Phase 1b proof‑of‑mechanism (PoM), and Phase 2a proof‑of‑concept (PoC) studies, with the scope to continue into later-stage clinical development as programs mature. The role requires deep expertise in early clinical development, strong scientific and operational judgment, and the ability to drive high‑quality execution in fast‑moving, innovative environments. This leader will shape the operational strategy for early programs, build a world‑class clinical operations function, and ensure seamless global execution across multiple geographies and regulatory landscapes.
Working through a cross-functional Clinical Operations Team, the VP of Clinical Operations will provide unified operational leadership, integrating scientific, clinical, regulatory, CMC, safety, translational, and commercial considerations into a coherent operational execution strategy and plan. This plan will reflect the program vision, Target Product Profile, and value proposition; define clear operational objectives and decision criteria; identify and manage critical risks; and enable timely, evidence-based decisions at key investment and governance milestones.
The VP of Clinical Operations will lead by influence across functions and geographies. They will create a high-performing Clinical Operations team with clear accountabilities, transparent decision-making, and strong execution discipline. The of Clinical Operations will work closely with Research, Pre-clinical Development, Clinical Development, Translational Science, Biomarkers, Clinical Pharmacology, Regulatory, CMC, Safety, DMPK/Clinical Pharmacology, Project Management, Finance and Business Development, and will represent the operational elements of the program at senior governance forums and with external partners as required. They will be expected to work seamlessly by working with contract research organizations (CROs) to recruit trial participants, oversee trial management, and maintain high data quality. This role reports to the Chief Medical Officer.
Key Accountabilities & Responsibilities
1. Clinical Operations Strategy & Leadership
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.
2. Pre-clinical Development & Transition to Clinic
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).
3. Clinical Execution & Proof of Concept (PoC)
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.
4. Integrated Project Planning & Risk Management
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.
5. Communication & Stakeholder Management
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).
6. Organizational Leadership, Quality & Safety
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.
Experience & Skills
Essential
Education: PhD, MD, PharmD, or advanced scientific/medical degree in immunology, inflammation, or a related field.
Experience: 7–10+ years of biotech/pharma clinical operations experience, with significant leadership responsibility for global early-phase trials (FIH to Phase 2a PoC).
Technical Mastery: Deep end-to-end understanding of drug development (nonclinical, translational medicine, regulatory, CMC, DMPK, clinical PK/PD).
Execution & Oversight: Strong track record delivering complex early-phase trials, governing CROs/vendors, managing global regulatory filings, and implementing safety oversight.
Leadership: Strategic thinking, stage-gate governance experience, cross-functional influencing, and ability to thrive in a fast-paced biotech environment.
Desirable
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.

Work arrangement
Yes