Executive Director, Clinical Pharmacokinetics

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and develop integrated pharmacokinetics (PK) and clinical pharmacology strategies throughout assigned drug-development programs, from early clinical phases to late-stage development and regulatory submission.

• Identify critical PK and exposure-response inquiries and formulate strategies to address them effectively.

• Convert findings from preclinical, translational, and early clinical PK studies into actionable recommendations for dose selection, dose escalation, dosing regimen optimization, and study design.

• Create cohesive PK strategies across individual clinical trials.

• Offer strategic contributions to development plans, clinical protocols, statistical analysis plans, clinical study reports, investigator materials, regulatory documents, and responses to regulatory inquiries.

• Assess the impact of formulation, route of administration, devices, dosage, and patient populations on systemic and local drug exposure.

• Combine PK data with pharmacodynamic, biomarker, efficacy, safety, and disease information for thorough benefit-risk assessments and development decisions.

• Recognize opportunities for modeling and simulation to expedite development, minimize uncertainty, and enhance clinical trial design.

• Provide PK leadership for Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), food-effect, drug-drug interaction, special-population, bioavailability/bioequivalence, dose-ranging, and pivotal studies.

• Develop appropriate PK sampling strategies and offer scientific guidance on sample collection, processing, bioanalytical requirements, and data management.

• Collaborate with Clinical Operations and study teams to incorporate PK components into clinical protocols.

• Analyze and interpret individual and population PK results, translating findings into clinical development recommendations.

• Merge PK assessments with safety, pharmacodynamic, biomarker, and efficacy endpoints.

• Supervise external PK and pharmacometric vendors and contract research organizations (CROs), including overseeing protocols, analysis plans, data reviews, deliverables, and quality assurance.

• Identify and resolve PK-related issues and deviations within studies.

• Lead population PK analyses, including objectives, analysis strategies, covariate assessments, modeling approaches, simulations, and dose optimization.

• Oversee and critically review NONMEM and other modeling and simulation analyses.

• Communicate model assumptions, limitations, and conclusions effectively.

• Provide PK and clinical pharmacology leadership for inhaled drug-development programs, addressing pulmonary deposition, respiratory absorption, local versus systemic exposure, formulation, and device considerations.

• Collaborate with formulation, device, Chemistry, Manufacturing, and Controls (CMC), translational, and clinical teams regarding the impacts of formulation and devices on exposure and clinical performance.

• Assist in interpreting inhaled drug PK data within the context of local pulmonary pharmacology and systemic pharmacokinetics.

• Offer senior-level PK and clinical pharmacology expertise during interactions with regulatory agencies.

• Develop and review PK/clinical pharmacology sections for IND/IMPD, NDA/BLA/MAA submissions, briefing documents, responses to information requests, and other regulatory materials.

• Participate in regulatory meetings and provide justifications for PK strategies, modeling approaches, dose selection, and clinical pharmacology conclusions.

• Anticipate regulatory inquiries and proactively address PK and pharmacometric concerns.

• Act as a 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 decision-making.

• Communicate intricate quantitative findings to both technical and non-technical stakeholders.

• Cultivate 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 field.

• Extensive experience in clinical pharmacokinetics and/or clinical pharmacology within the pharmaceutical or biotechnology sectors.

• Proven experience in developing and implementing PK strategies at both the drug/asset and individual clinical study levels.

• Strong proficiency in population PK and pharmacometric methodologies, including the interpretation and application of modeling and simulation in drug development decisions.

• Comprehensive understanding of the drug-development process from early clinical development to late-stage development and regulatory submission.

• Experience working collaboratively within multidisciplinary drug-development teams.

• Experience providing scientific leadership to internal teams and external CROs or consultants.

• Strong familiarity with PK study design, PK sampling strategies, bioanalysis, PK data interpretation, and principles of clinical pharmacology.

• Experience contributing to regulatory submissions and/or direct interactions with health authorities.

• Excellent scientific communication skills, capable of translating complex PK and modeling findings into clear development recommendations.

• Demonstrated ability to operate strategically while maintaining sufficient technical depth to critically evaluate PK and pharmacometric work.

• Preferred: Experience in inhaled drug development, pulmonary delivery, respiratory therapies, or other locally administered medications.

• Preferred: Experience with exposure-response modeling and/or pharmacodynamic modeling.

• Preferred: Experience using or overseeing NONMEM, Monolix, or similar population PK/pharmacometrics platforms.

• Preferred: Experience with clinical trial simulation and model-informed drug development (MIDD).

• Preferred: Experience in physiologically based pharmacokinetic (PBPK) modeling and simulation.

• Preferred: Experience supporting dose selection and optimization across diverse patient populations.

• Preferred: Experience with special populations, including those with renal or hepatic impairment, pediatrics, elderly populations, or other clinically relevant groups.

• Preferred: Experience with drug-drug interaction assessments and/or transporter-mediated interactions.

• Preferred: Experience in 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.