Executive Director, Clinical Pharmacokinetics

Job 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.

• 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.

Job 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.

Job benefits