[Hiring] Associate Director/Director, Clinical Pharmacology and Pharmacometrics @Dianthus Therapeutics

Role Description

The Associate Director, Clinical Pharmacology & Pharmacometrics will serve as a key quantitative sciences leader supporting the company's autoimmune/inflammation and neuromuscular disease portfolios. This individual will:

• Design, execute, and interpret quantitative systems pharmacology (QSP), population pharmacokinetic (PopPK), and exposure-response (E-R) analyses.
• Inform first-in-human (FIH) dose selection, Phase 2 dose selection/rationale, and lifecycle formulation/device bridging strategies.
• Utilize deep hands-on modeling expertise (MATLAB, NONMEM, R).
• Translate complex quantitative outputs into clear, decision-enabling recommendations for cross-functional teams and regulatory submissions.

This is a unique opportunity to positively impact lives as part of a team driven by continuous innovation with very high scientific integrity. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• QSP Modeling & First-in-Human Dose Selection
  • Develop and apply fit-for-purpose QSP models (MATLAB and associated MATLAB modules, e.g., SimBiology).
  • Conduct competitive landscape and benchmarking analyses.
  • Integrate nonclinical (in vitro/in vivo/NHP PK/PD) data with competitor-derived and mechanistic assumptions.
  • Lead quantitative dose-selection strategy for first-in-human studies.
  • Use R for exploratory data analysis, visualization, and model diagnostics.
• Population PK/PD and Exposure-Response Analysis
  • Build, qualify, and apply population pharmacokinetic (PopPK) models in NONMEM.
  • Perform exposure-response (E-R) analyses linking PK to relevant efficacy, safety, and biomarker endpoints.
  • Translate PopPK/E-R findings into Phase 2 dose and regimen recommendations.
  • Use R for dataset assembly, post-processing, diagnostics, and reporting of population modeling results.
  • Author and review analysis plans, statistical/pharmacometric analysis reports, and relevant sections of regulatory documents.
• Bioequivalence / Relative Bioavailability & Formulation Bridging
  • Leverage existing PopPK models to conduct bioequivalence (BE) and relative bioavailability analyses.
  • Support commercialization readiness for late-stage/marketed assets.
  • Design model-based simulation strategies to support waiver arguments or reduced clinical burden.
• Cross-Functional & Strategic Contributions
  • Partner with Clinical Development, Research, Translational Medicine, Bioanalytical, Biostatistics, Regulatory Affairs, and CMC.
  • Present modeling results and strategic recommendations to senior leadership and regulatory agencies.
  • Contribute to health authority interactions by preparing quantitative pharmacology responses and briefing materials.
  • Oversee CRO pharmacometricians/modelers and contribute to department-wide methodology and process improvements.

Experience

• Ph.D. in Pharmacometrics, Pharmaceutical Sciences, Clinical Pharmacology, Bioengineering, Systems Biology, or related quantitative discipline (PharmD with relevant pharmacometrics experience also considered).
• Minimum 6–8 years of relevant industry experience in clinical pharmacology/pharmacometrics.
• Demonstrated proficiency in QSP model development using MATLAB.
• Strong hands-on expertise in population PK/PD modeling using NONMEM.
• Proficiency in R for pharmacometric data analysis, visualization, and reporting.
• Experience translating nonclinical and early clinical data into human dose projections and Phase 2 dosing strategies.
• Experience with bioequivalence/relative bioavailability modeling approaches.
• Familiarity with autoimmune, inflammatory, and/or neuromuscular disease areas strongly preferred.
• Experience authoring pharmacometric sections of regulatory submissions.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Prior experience supporting subcutaneous biologic formulation/device lifecycle programs.
• Experience with competitive intelligence modeling and literature-based model informed drug development (MIDD) approaches.
• Prior direct interaction with FDA/EMA on clinical pharmacology or pharmacometric matters.
• People management or matrixed team leadership experience.