Associate Director, Clinical Pharmacology and Pharmacometrics - remote job

Dianthus Therapeutics is hiring a Associate Director, Clinical Pharmacology and Pharmacometrics - a lead role, which means responsibility for a team or a direction. The role sits in IT and programming and is fully remote. The company places no restriction on where the candidate lives, so you can apply from anywhere.

The employer did not publish a figure; that is settled at interview. The advert sets no condition on working hours.

This vacancy passed an automated check: the list excludes any advert requiring a foreign work permit, visa sponsorship, a particular citizenship, or residence in a specific country.

Company Overview We are pioneering innovative therapies for patients with severe autoimmune diseases. Our flagship product, claseprubart (DNTH103), is meticulously engineered to offer extended half-life, enhanced potency, and precise targeting of the C1s complement protein, crucial for disease progression, through subcutaneous injections that are both less frequent and more user-friendly. Our second clinical candidate, DNTH212, is a unique, potentially best-in-class, dual-function inhibitor that targets Type 1 IFN suppression and B cell modulation, aiming for improved therapeutic outcomes and convenient self-administration. For more information, visit [www.dianthustx.com](http://www.dianthustx.com) and follow us on LinkedIn.

Role Description As the Associate Director, Clinical Pharmacology & Pharmacometrics, you will be a pivotal leader in quantitative sciences, supporting our efforts in autoimmune and inflammation, as well as neuromuscular disease portfolios. You will design, execute, and interpret quantitative systems pharmacology (QSP), population pharmacokinetic (PopPK), and exposure-response (E-R) analyses to guide dose selection and lifecycle strategies. You will leverage skills in MATLAB, NONMEM, and R to deliver actionable insights for cross-functional teams and regulatory submissions.

This role offers a rare chance to make a positive impact on patient care, alongside a team dedicated to continuous innovation and high scientific standards. We foster a remote-friendly environment that aligns with our core values.

Key Responsibilities - QSP Modeling & First-in-Human Dose Selection - Develop and apply QSP models using MATLAB and SimBiology to understand target engagement, pharmacodynamics, and disease biology. - Integrate nonclinical and competitor data to refine human PK/PD simulations. - Lead the dose selection strategy for first-in-human studies, including dose justification and safety assessment.

- Population PK/PD and Exposure-Response Analysis - Build and apply PopPK models in NONMEM using Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) data. - Conduct E-R analyses to connect PK to efficacy, safety, and biomarker endpoints. - Translate PopPK/E-R findings into Phase 2 dosing recommendations, supporting clinical and regulatory teams.

- Bioequivalence & Formulation Bridging - Use existing PopPK models to validate new subcutaneous formulations and devices. - Ensure regulatory readiness for late-stage assets by bridging PK across different formulations.

- Cross-Functional Contributions - Collaborate with Clinical Development, Research, Translational Medicine, Bioanalytical, Biostatistics, Regulatory Affairs, and CMC to align quantitative strategies. - Present and advocate modeling results to senior leadership and regulatory agencies.

Experience Required - Education: Ph.D. in Pharmacometrics, Pharmaceutical Sciences, Clinical Pharmacology, Bioengineering, or related fields (PharmD with relevant experience also considered). - Industry Experience: At least 6-8 years in clinical pharmacology/pharmacometrics, with hands-on modeling experience. - Technical Skills: Proficiency in QSP modeling using MATLAB, population PK/PD modeling in NONMEM, and R for data analysis. - Disease Expertise: Experience in autoimmune, inflammatory, or neuromuscular diseases. - Regulatory Experience: Authoring sections of regulatory submissions and excellent communication skills.

Preferred Qualifications - Experience in subcutaneous biologic formulation/device lifecycle programs. - Competitor intelligence modeling and MIDD approaches. - Direct interaction with FDA/EMA. - Leadership experience.

Originally posted on Himalayas