Associate Director, Clinical Pharmacology, Pharmacometrics

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🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 16%

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

📋 Description

• Serve as a key quantitative sciences leader supporting autoimmune/inflammation and neuromuscular disease portfolios • Design, execute, and interpret QSP, population pharmacokinetic, and exposure-response analyses • Inform first-in-human dose selection, Phase 2 dose selection and rationale, and lifecycle formulation/device bridging strategies • Develop and apply fit-for-purpose QSP models using MATLAB and SimBiology to characterize target engagement, receptor occupancy, PK/PD relationships, and disease biology • Conduct competitive landscape and benchmarking analyses using public competitor PK/PD/clinical data • Integrate nonclinical, competitor-derived, and mechanistic data to simulate human PK/PD and support translational dose projections • Lead first-in-human quantitative dose-selection strategy, including starting-dose justification, dose-escalation simulation, and safety-margin assessment • Build, qualify, and apply PopPK models in NONMEM using SAD and MAD clinical study data • Perform exposure-response analyses linking PK to efficacy, safety, and biomarker endpoints across autoimmune and inflammatory indications • Translate PopPK and exposure-response findings into Phase 2 dose and regimen recommendations • Assemble datasets, conduct post-processing and diagnostics, and report population-modeling results using R • Author and review analysis plans, pharmacometric reports, and regulatory-document sections • Conduct bioequivalence and relative bioavailability analyses for new subcutaneous formulations, delivery devices, and injection sites • Quantitatively bridge PK across formulation, device, and site changes to support commercialization readiness • Design model-based simulation strategies for formulation/device bridging studies • Partner with Clinical Development, Research, Translational Medicine, Bioanalytical, Biostatistics, Regulatory Affairs, and CMC teams • Present modeling results and strategic recommendations to senior leadership, IND/NDA teams, and regulatory agencies • Contribute to FDA/EMA health-authority interactions and prepare quantitative pharmacology responses and briefing materials • Oversee CRO pharmacometricians/modelers and contribute to methodology and process improvements

🎯 Requirements

• 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, including 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 for formulation, device, or route/site bridging • Familiarity with autoimmune, inflammatory, and/or neuromuscular disease areas strongly preferred • Experience authoring pharmacometric sections of regulatory submissions, including IND/CTA, briefing documents, and NDA/BLA • Excellent written and verbal communication skills, with ability to convey complex quantitative concepts to non-technical stakeholders • Prior experience supporting subcutaneous biologic formulation/device lifecycle programs preferred • Experience with competitive intelligence modeling and literature-based MIDD approaches preferred • Prior direct interaction with FDA/EMA on clinical pharmacology or pharmacometric matters preferred • People management or matrixed team leadership experience preferred

🏖️ Benefits

• Remote work opportunity • Opportunity to positively impact patients’ lives • Continuous innovation and high scientific integrity culture