Associate Director, Clinical Pharmacology, Pharmacometrics

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a pivotal leader in quantitative sciences for autoimmune/inflammation and neuromuscular disease portfolios.

• Design, implement, and analyze quantitative systems pharmacology (QSP), population pharmacokinetic, and exposure-response studies.

• Provide insights for first-in-human dose determination, Phase 2 dose strategy and justification, and formulation/device transition strategies throughout the product lifecycle.

• Create and utilize tailored QSP models through MATLAB and SimBiology to understand target engagement, receptor occupancy, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and disease biology.

• Execute competitive analysis and benchmarking utilizing publicly available competitor PK/PD/clinical data.

• Combine nonclinical, competitor-derived, and mechanistic data to simulate human PK/PD and support translational dose forecasting.

• Lead the quantitative dose-selection strategy for first-in-human studies, encompassing starting-dose justification, dose-escalation simulations, and safety-margin evaluations.

• Develop, validate, and implement population PK models in NONMEM with data from single ascending dose (SAD) and multiple ascending dose (MAD) clinical studies.

• Conduct exposure-response evaluations linking pharmacokinetics to efficacy, safety, and biomarker endpoints across autoimmune and inflammatory conditions.

• Transform findings from population PK and exposure-response analyses into recommendations for Phase 2 dosing and treatment regimens.

• Gather datasets, execute post-processing and diagnostics, and present population modeling outcomes using R.

• Prepare and review analysis plans, pharmacometric reports, and sections of regulatory documents.

• Perform bioequivalence and relative bioavailability assessments for new subcutaneous formulations, delivery devices, and injection sites.

• Quantitatively connect pharmacokinetics across changes in formulation, device, and site to facilitate commercialization readiness.

• Develop model-based simulation methodologies for formulation/device transition studies.

• Collaborate with Clinical Development, Research, Translational Medicine, Bioanalytical, Biostatistics, Regulatory Affairs, and CMC teams.

• Present modeling outcomes and strategic recommendations to senior leadership, IND/NDA teams, and regulatory bodies.

• Contribute to interactions with FDA/EMA and prepare quantitative pharmacology responses and briefing materials.

• Supervise CRO pharmacometricians/modelers and participate in improving methodologies and processes.

⛳️ Requirements

• Ph.D. in Pharmacometrics, Pharmaceutical Sciences, Clinical Pharmacology, Bioengineering, Systems Biology, or a related quantitative field; a PharmD with relevant pharmacometrics experience is also acceptable.

• At least 6–8 years of pertinent industry experience in clinical pharmacology/pharmacometrics, demonstrating practical modeling expertise.

• Proven proficiency in developing QSP models utilizing MATLAB and modules such as SimBiology or equivalent tools.

• Strong practical knowledge of population PK/PD modeling with NONMEM, including data preparation, model diagnostics, and simulation techniques.

• Proficient in R for conducting pharmacometric data analysis, visualization, and reporting, including packages like tidyverse, xpose, ggplot2, or similar.

• Experience in translating nonclinical and early clinical SAD/MAD data into human dose forecasts and Phase 2 dosing plans.

• Background in bioequivalence/relative bioavailability modeling for formulation, device, or route/site transitions.

• Familiarity with autoimmune, inflammatory, and/or neuromuscular disease areas is highly preferred.

• Experience in authoring pharmacometric sections of regulatory submissions, including IND/CTA, briefing documents, and NDA/BLA.

• Strong written and verbal communication skills, with the ability to explain complex quantitative concepts to non-technical audiences.

• Prior experience supporting subcutaneous biologic formulation/device lifecycle programs is preferred.

• Experience with competitive intelligence modeling and literature-based Model-Informed Drug Development (MIDD) strategies is preferred.

• Previous direct engagement with FDA/EMA concerning clinical pharmacology or pharmacometric issues is preferred.

• Experience in people management or leading matrixed teams is preferred.

🏝️ Benefits

• Opportunity for remote work.

• Chance to make a positive impact on patients’ lives.

• Culture of continuous innovation and high scientific integrity.