Executive Director, Clinical Pharmacokinetics

Liquidia•,

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
Provide strategic leadership for population PK analyses across clinical development programs.
Define appropriate population PK objectives, analysis strategies, covariate assessments, and modeling approaches.
Oversee development and review of population PK models, exposure-response analyses, and associated simulations.
Ensure appropriate evaluation of sources of PK variability, including demographic characteristics, disease status, organ function, concomitant medications, formulation, dose, route of administration, and other clinically relevant covariates.
Use population PK and pharmacometric analyses to inform dose optimization and dosing recommendations for relevant patient populations.
Integrate population PK findings with exposure-response relationships and other quantitative analyses to support clinical decision making.
Provide oversight and scientific review of NONMEM or other appropriate modeling and simulation analyses conducted internally or externally.
Ensure appropriate interpretation, documentation, and communication of model assumptions, limitations, and conclusions.
Provide PK/clinical pharmacology leadership for inhaled drug-development programs, where applicable.
Apply knowledge of the unique PK characteristics of inhaled therapies, including pulmonary deposition, absorption from the respiratory tract, local versus systemic exposure, first-pass effects, particle/formulation characteristics, and device-related considerations.
Partner with formulation, device, CMC, translational, and clinical teams to understand the impact of formulation and device changes on exposure and clinical performance.
Contribute to strategies for evaluating pulmonary and systemic exposure and their relationship to pharmacodynamic, efficacy, and safety outcomes.
Provide scientific input into development strategies addressing differences in inhalation technique, device use, patient characteristics, and other factors that may influence drug delivery and exposure.
Support interpretation of inhaled drug PK data in the context of both local pulmonary pharmacology and systemic pharmacokinetics.
Provide senior-level PK and clinical pharmacology expertise in interactions with regulatory agencies.
Develop and review PK/clinical pharmacology sections of regulatory submissions, including relevant portions of IND/IMPD, NDA/BLA/MAA, briefing documents, responses to information requests, and other regulatory materials.
Participate in regulatory meetings and provide clear scientific rationale for PK strategies, modeling approaches, dose selection, and clinical pharmacology conclusions.
Anticipate regulatory questions and proactively develop strategies to address potential PK and pharmacometric concerns.
Maintain awareness of evolving regulatory expectations and scientific standards relevant to clinical pharmacology, PK, population PK, exposure-response, and modeling and simulation.
Serve as the senior PK subject-matter expert and strategic partner to Clinical Development and broader development teams.
Work collaboratively with Clinical Pharmacology, Biostatistics, Data Science, Translational Medicine, Biomarkers, CMC, Toxicology, Regulatory Affairs, and Clinical Operations.
Contribute PK and quantitative clinical pharmacology expertise to program governance and portfolio decision-making.
Clearly communicate complex quantitative findings to both technical and non-technical stakeholders.
Challenge assumptions constructively and ensure that PK considerations are appropriately incorporated into development decisions.
Build strong relationships with internal stakeholders, external experts, academic collaborators, and strategic partners.