Executive Director, Clinical Pharmacokinetics
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Job Description
Executive Director leading clinical pharmacokinetics and pharmacometrics strategy for Liquidia’s pulmonary hypertension therapies. Guiding studies, modeling, regulatory submissions, and cross-functional drug development.
Responsibilities:
- Develop and lead integrated PK/clinical pharmacology strategies across assigned drug-development programs from early clinical development through late-stage development and regulatory submission
- Define key PK and exposure-response questions and establish strategies to address them
- Translate preclinical, translational, and early clinical PK findings into recommendations for dose selection, dose escalation, dosing regimen optimization, and study design
- Establish coherent PK strategies across individual clinical studies
- Provide strategic input into development plans, clinical protocols, statistical analysis plans, clinical study reports, investigator materials, regulatory documents, and responses to regulatory questions
- Evaluate effects of formulation, route of administration, device, dose, and patient population on systemic and local drug exposure
- Integrate PK data with pharmacodynamic, biomarker, efficacy, safety, and disease information for quantitative benefit-risk assessment and development decisions
- Identify modeling and simulation opportunities to accelerate development, reduce uncertainty, and optimize clinical trial design
- Provide PK leadership for SAD/MAD, food-effect, drug-drug interaction, special-population, bioavailability/bioequivalence, dose-ranging, and pivotal studies
- Develop fit-for-purpose PK sampling strategies and provide scientific input on sample collection, processing, bioanalytical requirements, and data management
- Partner with Clinical Operations and study teams to implement PK components in clinical protocols
- Review and interpret individual and population PK results and translate findings into clinical development recommendations
- Integrate PK assessments with safety, pharmacodynamic, biomarker, and efficacy endpoints
- Oversee external PK and pharmacometric vendors and CROs, including protocols, analysis plans, data review, deliverables, and quality
- Identify and resolve PK-related study issues and deviations
- Lead population PK analyses, including objectives, analysis strategies, covariate assessments, modeling approaches, simulations, and dose optimization
- Oversee and scientifically review NONMEM and other modeling and simulation analyses
- Communicate model assumptions, limitations, and conclusions
- Provide PK/clinical pharmacology leadership for inhaled drug-development programs, including pulmonary deposition, respiratory absorption, local versus systemic exposure, formulation, and device considerations
- Partner with formulation, device, CMC, translational, and clinical teams on formulation and device impacts on exposure and clinical performance
- Support interpretation of inhaled drug PK data in the context of local pulmonary pharmacology and systemic pharmacokinetics
- Provide senior-level PK and clinical pharmacology expertise in regulatory agency interactions
- Develop and review PK/clinical pharmacology sections of IND/IMPD, NDA/BLA/MAA, briefing documents, responses to information requests, and other regulatory materials
- Participate in regulatory meetings and provide rationale for PK strategies, modeling approaches, dose selection, and clinical pharmacology conclusions
- Anticipate regulatory questions and address PK and pharmacometric concerns
- Serve as senior PK subject-matter expert and strategic partner to Clinical Development and broader development teams
- Collaborate with Clinical Pharmacology, Biostatistics, Data Science, Translational Medicine, Biomarkers, CMC, Toxicology, Regulatory Affairs, and Clinical Operations
- Contribute quantitative clinical pharmacology expertise to program governance and portfolio decisions
- Communicate complex quantitative findings to technical and non-technical stakeholders
- Build relationships with internal stakeholders, external experts, academic collaborators, and strategic partners
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
- Preferred: Experience with inhaled drug development, pulmonary delivery, respiratory therapies, or other locally administered drugs
- Preferred: Experience with exposure-response modeling and/or pharmacodynamic modeling
- Preferred: Experience using or overseeing NONMEM, Monolix, or comparable population PK/pharmacometrics platforms
- Preferred: Experience with clinical trial simulation and model-informed drug development (MIDD)
- Preferred: Experience with physiologically based pharmacokinetic (PBPK) modeling and simulation
- Preferred: Experience supporting dose selection and optimization across different patient populations
- Preferred: Experience with special populations, including renal or hepatic impairment, pediatrics, elderly populations, or other clinically relevant populations
- Preferred: Experience with drug-drug interaction assessment and/or transporter-mediated interactions
- Preferred: Experience with regulatory interactions specifically related to clinical pharmacology, PK, population PK, and modeling and simulation
- Preferred: Peer-reviewed publications, conference presentations, or other evidence of scientific leadership in clinical pharmacology, pharmacokinetics, or pharmacometrics
Benefits:
- Competitive compensation package
- Medical insurance
- Dental insurance
- Vision insurance
- Short-term disability (STD)
- Long-term disability (LTD)
- 401(k) Savings Retirement Plan
- Employee Stock Purchase Plan (ESPP)
- Reasonable accommodation for qualified individuals with disabilities
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