[Remote] VP of Clinical Development

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 Development will lead the clinical strategy and delivery of its pipeline from candidate selection and early clinical studies through proof of concept, while overseeing clinical teams and coordinating cross-functional development activities.

Responsibilities

• Global Strategy : Define and drive the global clinical development strategy for early-stage programs (FIH, Phase 1, Phase 1b PoM, Phase 2a PoC) with expansion into later-stage development as programs mature
• Team Leadership : Provide scientific leadership, coaching, and oversight to Clinical Leads and Clinical Scientists; ensure high-quality CDP, protocols, investigator brochures, analysis plans, and regulatory filings
• Operations & Vendor Governance : Partner with Clinical Operations on study execution (country/site selection, enrollment assumptions, timelines, budgets) and CRO/vendor selection, contracting, and governance
• Core Decisions : Drive key clinical decisions regarding dose selection, cohort design, target patient populations, endpoints, biomarker integration, and benefit-risk assessments for immune-mediated diseases
• Candidate-to-Clinic Execution : Lead integrated transition planning from candidate selection through IND/CTA clearance and FIH initiation with clear milestones, governance, and budgets
• Cross-Functional Alignment : Coordinate across Pharmacology, DMPK, Toxicology, Safety, Bioanalysis, CMC, Quality, Translational Medicine, and Regulatory for clinical readiness
• Translational Science : Translate nonclinical pharmacology and exposure-response data into starting dose, escalation strategies, biomarker plans, and PoM/PoC hypotheses
• Regulatory & Supply Readiness : Ensure GMP supply chain readiness and lead operational aspects of IND/CTA submissions, health authority interactions, dose-escalation processes, and risk mitigations (under GLP/GMP/GCP)
• Trial Execution : Design and deliver high-quality early-phase studies testing key hypotheses to generate decision-quality data on safety, tolerability, PK/PD, target engagement, and efficacy
• Data Integration & Adaptation : Adapt dose, schedule, cohort, indication, and endpoint decisions based on emerging clinical, translational, and safety data
• Later-Stage Hand-Off : Maintain a clear pathway from PoC to late-stage development and registration (endpoints, comparators, regulatory path)
• Program Ownership : Own the integrated clinical development plan, critical paths, dependencies, and budgets in partnership with cross-functional leadership
• Risk & Governance : Proactively identify scientific, regulatory, operational, and commercial risks; establish mitigation strategies and balance speed with quality, safety, and compliance
• Strategic Representation : Serve as the primary clinical spokesperson internally (presenting strategies and investment proposals to senior leadership) and externally (KOLs, development partners, and BD due diligence)
• Team Building : Mentor a high-performing clinical team, define roles/decision rights, and foster a patient-focused, data-driven culture
• Compliance : Ensure all program activities comply with ICH-GCP, GMP, regulatory expectations, ethical standards, and safety principles, rapidly escalating any issues

Skills

• MD or MD-PhD (or equivalent medical qualification) in a relevant clinical discipline with a strong background in immune-mediated diseases or related areas
• 7–10+ years of biotech/pharma clinical development experience, with demonstrated leadership of global early-phase programs (FIH to Phase 2a PoC)
• Deep understanding of end-to-end drug development (nonclinical, clinical, translational science, regulatory, CMC, safety, DMPK/clinical pharmacology)
• Proven track record in CRO governance, global regulatory filing requirements, trial design, medical/safety monitoring, and data interpretation
• Strategic thinking, stage-gate governance experience, cross-functional influencing, and ability to thrive in a fast-paced biotech environment
• Domain experience in immunological diseases (dermatology, rheumatology, gastroenterology, respiratory) and relevant therapeutic modalities (biologics, antibodies, multispecifics, oral modalities)
• Proven track record taking a program through PoC into late-stage development
• Experience with IND/CTA submissions across major global health authorities (US, China, Europe)
• Background in external partnerships, licensing, BD due diligence, or alliance management

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