[Hiring] Executive Director, Clinical Pharmacokinetics @Liquidia

Role Description

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
• Other functions

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
• 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.

Qualifications

• 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