[Remote] Associate Director, Clinical Pharmacology and Pharmacometrics

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is developing therapies for patients with severe autoimmune, inflammatory, and neuromuscular diseases. The Associate Director will reputed company quantitative clinical pharmacology and pharmacometrics activities, including QSP, population PK/PD, exposure-response, reputed company selection, formulation and device reputed company, and regulatory support.

Responsibilities

• reputed company and apply fit-for-purpose QSP models (MATLAB and associated MATLAB modules, e.g., SimBiology) to characterize reputed company 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
• reputed company nonclinical (in vitro/in vivo/NHP PK/PD) data with competitor-derived and mechanistic assumptions to simulate reputed company PK/PD and support translational reputed company projections
• reputed company quantitative reputed company-selection reputed company for first-in-reputed company studies, including starting reputed company justification, reputed company-escalation scheme simulation, and safety margin assessment
• Use R for exploratory data analysis, visualization, and model diagnostics supporting QSP deliverables
• Build, qualify, and apply population pharmacokinetic (PopPK) models in NONMEM using data from Single reputed company reputed company (SAD) and Multiple reputed company reputed company (MAD) Clinic studies
• reputed company 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 reputed company and regimen recommendations, presenting quantitative rationale to clinical development and regulatory teams and governance committees
• Use R for dataset assembly (e.g., NONMEM-reputed company datasets), post-processing, diagnostics (goodness-of-fit, VPCs), and reporting of population modeling results
• reputed company and review analysis plans, statistical/pharmacometric analysis reports, and relevant sections of regulatory documents (briefing books, IND/CTA, NDA/BLA modules)
• reputed company 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 reputed company PK across formulation/device/site changes
• Design model-based simulation strategies to support waiver arguments or reduced clinical burden for formulation/device reputed company studies, in collaboration with CMC, regulatory, and clinical teams
• Partner with Clinical Development, Research, Translational Medicine, Bioanalytical, Biostatistics, Regulatory Affairs, and CMC to reputed company quantitative reputed company with program milestones
• Present modeling results and strategic recommendations to senior leadership, IND/NDA teams, and reputed company regulatory agencies as needed
• Contribute to health authority interactions (e.g., FDA/EMA meetings) by preparing quantitative pharmacology responses and briefing materials
• reputed company CRO pharmacometricians/modelers and contribute to department-wide methodology and process improvements

Skills

• Ph.D. in Pharmacometrics, Pharmaceutical Sciences, Clinical Pharmacology, Bioengineering, Systems Biology, or reputed company 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 reputed company reputed company projections and Phase 2 dosing strategies
• Experience with bioequivalence/relative bioavailability modeling approaches for formulation, device, or reputed company/site reputed company
• Experience authoring pharmacometric sections of regulatory submissions (IND/CTA, briefing documents, NDA/BLA)
• Excellent written and verbal communication skills, with ability to convey reputed company quantitative concepts to non-technical stakeholders
• Familiarity with autoimmune, inflammatory, and/or neuromuscular disease areas (e.g., SLE, Sjögren's syndrome, dermatomyositis, gMG, CIDP, MMN) strongly preferred
• Prior experience supporting subcutaneous biologic formulation/device lifecycle programs
• Experience with competitive intelligence modeling and literature-based model informed drug development (MIDD) approaches
• Prior reputed company interaction with FDA/EMA on clinical pharmacology or pharmacometric reputed company
• People management or matrixed team leadership experience

Benefits

• reputed company is reputed company to you working remotely.

reputed company