Associate Director, Clinical Pharmacology and Pharmacometrics

About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn . About the Role 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 to inform first-in-human (FIH) dose selection, Phase 2 dose selection/rationale, and lifecycle formulation/device bridging strategies. The role requires deep hands-on modeling expertise (MATLAB, NONMEM, R) combined with the ability to translate complex quantitative outputs into clear, decision-enabling recommendations for cross-functional teams and regulatory submissions. This is a unique opportunity where you have a chance to positively impact lives as part of the team driven by continuous innovation with very high scientific integrity. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. 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 fit-for-purpose QSP models (MATLAB and associated MATLAB modules, e.g., SimBiology) to characterize target engagement/coverage, RO, PK/PD relationships, and disease-relevant biology in autoimmunity and inflammation programs. - Conduct competitive landscape and benchmarking analyses, integrating publicly available competitor PK/PD/clinical data into modeling frameworks to contextualize internal program positioning. - Integrate nonclinical (in vitro/in vivo/NHP PK/PD) data with competitor-derived and mechanistic assumptions to simulate human PK/PD and support translational dose projections. - Lead quantitative dose-selection strategy for first-in-human studies, including starting dose justification, dose-escalation scheme simulation, and safety margin assessment. - Use R for exploratory data analysis, visualization, and model diagnostics supporting QSP deliverables. Population PK/PD and Exposure-Response Analysis - Build, qualify, and population pharmacokinetic (PopPK) models in NONMEM using data from Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Clinic studies. - Perform exposure-response (E-R) analyses linking PK to relevant efficacy, safety, and biomarker endpoints across autoimmune/inflamation indications including Systemic Lupus Erythematosus (SLE), rheumatoid arthritis (RA), Sjögren's syndrome, and dermatomyositis. - Translate PopPK/E-R findings into Phase 2 dose and regimen recommendations, presenting quantitative rationale to clinical development and regulatory teams and governance committees. - Use R for dataset assembly (e.g., NONMEM-ready datasets), post-processing, diagnostics (goodness-of-fit, VPCs), and reporting of population modeling results. - Author and review analysis plans, statistical/pharmacometric analysis reports, and relevant sec