[Remote] Senior or Exec Director of Clinical Pharmacology and Pharmacometrics Leader

Note: The job is a remote job and is open to candidates in USA. Ailux is seeking a clinical pharmacology and pharmacometrics leader to guide quantitative drug development from preclinical translation through clinical proof-of-concept and later-stage development. The role leads clinical pharmacology strategy, modeling and dose optimization, vendor oversight, regulatory interactions, and development of the company’s clinical pharmacology and pharmacometrics capabilities.

Responsibilities

• Strategy & MIDD Plans : Develop global clinical pharmacology and MIDD plans integrating nonclinical/clinical PK/PD, exposure-response, biomarkers, efficacy, safety, and immunogenicity
• Quantitative Recommendations : Provide data-driven guidance on FIH starting doses, escalation schemes, dosing frequency, formulations, food-effect studies, and special populations
• Modeling & Simulation : Direct population PK, PK/PD, exposure-response, PBPK, translational modeling, and clinical trial simulations to guide portfolio decisions
• Candidate-to-Clinic Translation : Translate nonclinical pharmacology, DMPK, toxicology, bioanalytical, and biomarker data into human PK projections, therapeutic exposure targets, and safety margins
• Trial Design & Sampling : Partner with CMC, Formulation, and Clinical Ops to establish viable PK/PD/biomarker sampling plans, formulation comparability, and IND/CTA-enabling strategy
• Dose Optimization : Integrate emerging PK/PD, safety, efficacy, and immunogenicity data to refine dosing for biologics (TMDD, body-size effects, subcutaneous vs. IV) and oral agents (absorption, food effect, DDI, organ impairment)
• Late-Stage Alignment : Establish a clear quantitative pathway from PoC to registration, including dose justification, special population labeling, and post-approval commitments
• Execution & Oversight : Own integrated CPP plans, milestones, and budgets; select and govern external pharmacometrics, bioanalytical, and modeling vendors for quality and reproducibility
• Risk Mitigation : Proactively identify quantitative and translational risks, balancing development speed with scientific rigor, safety, and regulatory acceptability
• Spokesperson : Serve as the primary CPP internal expert and external representative to health authorities (FDA/EMA/NMPA), KOLs, and governance boards
• Business Development : Support partnering, licensing, and due diligence activities by evaluating translational models, human PK projections, and dose feasibility
• Capability Building : Build a scalable CPP function using internal experts, vendors, and consultants; define reusable quantitative workflows, model documentation, and data standards
• Regulatory Compliance : Ensure models, code, data sets, and reports comply with GCP/GLP, data integrity standards, and inspection readiness

Skills

• PhD, PharmD, MD , or equivalent in clinical pharmacology, pharmacometrics, pharmaceutical sciences, or quantitative discipline
• 5–7+ years of biotech/pharma CPP or MIDD leadership experience spanning candidate selection through FIH, dose optimization, PoC, and later-stage development
• Deep hands-on expertise in population PK, PK/PD, exposure-response modeling, clinical trial simulation, and reproducible programming workflows
• Proven record authoring CPP submission sections and defending dose justification strategies before major health authorities (FDA, EMA, NMPA)
• Demonstrated track record integrating cross-functional data (CMC, Safety, Biomarkers) and governing external modeling/bioanalytical vendors
• Experience in immunology, inflammation, dermatology, rheumatology, or gastroenterology
• Background supporting both biologics (antibodies, multispecifics, TMDD, immunogenicity) and oral therapeutic modalities (DDI, absorption, food effect)
• Exposure to advanced quantitative tools (PBPK, QSP, disease-progression modeling, model-based meta-analysis)
• Multi-regional development experience across the US, China, and Europe
• A scientific leader who moves seamlessly between complex quantitative model outputs and high-level portfolio strategy
• Decisive, collaborative, and comfortable with ambiguity, this individual influences cross-functional teams without hierarchical authority, establishing traceable and rigorous quantitative rationale for key drug development choices

Company Overview