Senior Director, Clinical Pharmacology & Pharmacometrics

AiLux S.r.l.; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Ailux, a biotechnology company leveraging AI to accelerate biologic therapies, seeks a scientific CPP leader to guide global pharmacometrics from preclinical to PoC and beyond. You will build scalable quantitative workflows, oversee vendors, ensure regulatory readiness, and drive dose selection with leadership collaboration across US, Europe, and China.

The role requires deep expertise in population PK/PD, PBPK and translational modeling, and strong cross-functional leadership to advance

Qualifications

• 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).
• Experience in immunology, inflammation, dermatology, rheumatology, or gastroenterology; cross-functional/vendor oversight.

Responsibilities

• Develop global CPP and MIDD plans integrating nonclinical/clinical PK/PD, exposure–response, biomarkers, efficacy, safety, and immunogenicity.
• Provide data-driven guidance on FIH starting doses, escalation schemes, dosing frequency, formulations, food-effect studies, and special populations.
• Direct population PK, PK/PD, exposure–response, PBPK, translational modeling, and clinical trial simulations to guide portfolio decisions.
• Translate nonclinical pharmacology, DMPK, toxicology, bioanalytical, and biomarker data into human PK projections and safety margins.
• Partner with CMC, Formulation, and Clinical Ops to establish viable PK/PD/biomarker sampling plans and IND/CTA-enabling strategy.
• Own integrated CPP plans, milestones, and budgets; select and govern external pharmacometrics, bioanalytical, and modeling vendors; mitigate risks.
• Serve as the CPP spokesperson to health authorities and support partnering, licensing, and due diligence activities with translational models and dose feasibility.

Skills

Population PK

PK/PD modeling

Exposure–response

PBPK

Modeling workflows

Regulatory submissions

Vendor oversight

Cross-functional collaboration

Immunology knowledge

Education

PhD, PharmD, MD

Tools

PBPK

QSP

Job description

Ailux, a biotechnology company leveraging AI to accelerate biologic therapies, seeks a scientific CPP leader to guide global pharmacometrics from preclinical to PoC and beyond. You will build scalable quantitative workflows, oversee vendors, ensure regulatory readiness, and drive dose selection with leadership collaboration across US, Europe, and China.

The role requires deep expertise in population PK/PD, PBPK and translational modeling, and strong cross-functional leadership to advance