Executive Director, Clinical Pharmacokinetics

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• 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