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 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. Remote work is supported.

Responsibilities

• QSP Modeling & First-in-Human Dose Selection
  • Develop and apply fit-for-purpose QSP models (MATLAB and associated modules, e.g., SimBiology) to characterize target engagement/coverage, receptor occupancy (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 apply population pharmacokinetic (PopPK) models in NONMEM using data from Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) clinical studies.
  • Perform exposure-response (E-R) analyses linking PK to relevant efficacy, safety, and biomarker endpoints across autoimmune/inflammation 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 sections of regulatory documents (briefing books, IND/CTA, NDA/BLA modules).
• Bioequivalence / Relative Bioavailability & Formulation Bridging
  • Leverage existing PopPK models to conduct bioequivalence (BE) and relative bioavailability analyses supporting introduction of new subcutaneous (SC) formulations, delivery devices, and/or injection sites.
  • Support commercialization readiness for late-stage/marketed assets in autoimmune/inflammation and neuromuscular disease/indications including but not limited to generalized myasthenia gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN) by quantitatively bridging PK across formulation/device/site changes.
  • Design model-based simulation strategies to support waiver arguments or reduced clinical burden for formulation/device bridging studies, in collaboration with CMC, regulatory, and clinical teams.
• Cross-Functional & Strategic Contributions
  • Partner with Clinical Development, Research, Translational Medicine, Bioanalytical, Biostatistics, Regulatory Affairs, and CMC to align quantitative strategy with program milestones.
  • Present modeling results and strategic recommendations to senior leadership, IND/NDA teams, and external regulatory agencies as needed.
  • Contribute to health authority interactions (e.g., FDA/EMA meetings) by preparing quantitative pharmacology responses and briefing materials.
  • Oversee CRO pharmacometricians/modelers and contribute to department-wide methodology and process improvements.

Qualifications

• 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, with demonstrated hands-on modeling ownership.
• Demonstrated proficiency in QSP model development using MATLAB (and modules such as SimBiology or equivalent).
• Strong hands-on expertise in population PK/PD modeling using NONMEM, including dataset preparation, model diagnostics, and simulation.
• Proficiency in R for pharmacometric data analysis, visualization, and reporting (e.g., tidyverse, xpose, ggplot2, or similar packages).
• Experience translating nonclinical and early clinical (SAD/MAD) data into human dose projections and Phase 2 dosing strategies.
• Experience with bioequivalence/relative bioavailability modeling approaches for formulation, device, or route/site bridging.
• Familiarity with autoimmune, inflammatory, and/or neuromuscular disease areas (e.g., SLE, Sjögren's syndrome, dermatomyositis, gMG, CIDP, MMN) strongly preferred.
• Experience authoring pharmacometric sections of regulatory submissions (IND/CTA, briefing documents, NDA/BLA).
• Excellent written and verbal communication skills, with ability to convey complex quantitative concepts to non-technical stakeholders.

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.