Executive Director, Clinical Pharmacokinetics

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary The Executive Director, Clinical Pharmacokinetics will provide strategic and scientific leadership for pharmacokinetic (PK) and pharmacometrics activities across the drug development portfolio, with primary responsibility for translating clinical pharmacology and PK principles into actionable development strategies at the asset, individual clinical study, and population PK levels.

This is a senior scientific leadership role requiring a strong understanding of drug development, clinical pharmacology, pharmacokinetics, pharmacometrics, and quantitative clinical pharmacology. The successful candidate will partner closely with Clinical Development, Regulatory, Biostatistics, CMC, and other functions to define and execute PK strategies that support efficient development and evidence-based decision making. Particular emphasis will be placed on candidates with experience in inhaled drug development, including understanding of the unique PK, pulmonary, formulation, device, and systemic exposure considerations associated with inhaled therapies.

The individual will be expected to serve as a recognized subject-matter expert, provide scientific direction to internal and external teams, and communicate complex PK concepts and analyses clearly to senior leadership, clinical teams, regulatory agencies, and external scientific collaborators. The role would report to the Chief Development Officer, working closely with development and operations colleagues within clinical development. PhD or equivalent doctoral degree in Pharmacokinetics, Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Clinical Pharmacology, Biopharmaceutics, or a closely related discipline.

Extensive experience in clinical pharmacokinetics and/or clinical pharmacology within the pharmaceutical or biotechnology industry.

Demonstrated experience developing and implementing PK strategies at the drug/asset level and individual clinical study level.

Strong experience with population PK and pharmacometric approaches, including interpretation and application of modeling and simulation to drug development decisions.

Demonstrated understanding of the drug-development process from early clinical development through late-stage development and regulatory submission.

Experience working cross-functionally in multidisciplinary drug-development teams.

Experience providing scientific leadership for internal teams and external CROs or consultants.

Strong understanding of PK study design, PK sampling strategies, bioanalysis, PK data interpretation, and clinical pharmacology principles.

Experience contributing to regulatory submissions and/or direct interactions with health authorities.

Excellent scientific communication skills, with the ability to translate complex PK and modeling results into clear development recommendations.

Demonstrated ability to operate strategically while maintaining sufficient technical depth to critically evaluate PK and pharmacometric work.

Preferred Qualifications

Experience with inhaled drug development, pulmonary delivery, respiratory therapies, or other locally administered drugs where systemic PK and local exposure require integrated interpretation.

Experience with exposure-response modeling and/or pharmacodynamic modeling.

Experience using or overseeing NONMEM, Monolix, or comparable population PK/pharmacometrics platforms.

Experience with clinical trial simulation and model-informed drug development (MIDD).

Experience with physiologically based pharmacokinetic (PBPK) modeling and simulation.

Experience supporting dose selection and optimization across different patient populations.

Experience with special populations, including renal or hepatic impairment, pediatrics, elderly populations, or other clinically relevant populations.

Experience with drug-drug interaction assessment and/or transporter-mediated interactions.

Experience with regulatory interactions specifically related to clinical pharmacology, PK, population PK, and modeling and simulation.

Peer-reviewed publications, conference presentations, or other evidence of scientific leadership in clinical pharmacology, pharmacokinetics, or pharmacometrics.

Asset-Level PK and Clinical Pharmacology Strategy Develop and lead integrated PK/clinical pharmacology strategies across the lifecycle of assigned drug-development programs, from early clinical development through late-stage development and regulatory submission.

Define the key PK and exposure-response questions that need to be addressed at each stage of development and establish appropriate strategies to answer them.

Translate preclinical, translational, and early clinical PK findings into development recommendations, including dose selection, dose escalation, dosing regimen optimization, and study design.

Establish a coherent PK strategy across individual clinical studies, ensuring that studies collectively address the key clinical pharmacology questions for the asset.

Provide strategic input into development plans, clinical protocols, statistical analysis plans, clinical study reports, investigator materials, regulatory documents, and responses to regulatory questions.

Evaluate the implications of formulation, route of administration, device, dose, and patient population on systemic and, where relevant, local drug exposure.

Integrate PK data with pharmacodynamic, biomarker, efficacy, safety, and disease-related information to support quantitative benefit-risk assessment and development decisions.

Identify opportunities to use modeling and simulation to accelerate development, reduce uncertainty, and optimize clinical trial design.

Clinical Study PK Strategy and Execution

Provide PK leadership for individual clinical studies, including SAD/MAD, food-effect, drug-drug interaction, special-population, bioavailability/bioequivalence, dose-ranging, and pivotal studies as appropriate.

Develop fit-for-purpose PK sampling strategies and provide scientific input into sample collection, processing, bioanalytical requirements, and data management.

Partner with Clinical Operations and study teams to ensure robust implementation of PK components within clinical protocols.

Review and interpret individual and population PK results and translate findings into clear clinical development recommendations.

Ensure appropriate integration of PK assessments with safety, pharmacodynamic, biomarker, and efficacy endpoints.

Provide scientific oversight of external PK and pharmacometric vendors and CROs, including protocol development, analysis plans, data review, deliverables, and quality.

Ensure timely identification and resolution of PK-related study issues and deviations.

Population PK and Pharmacometric Strategy Provide strategic lea