Senior Advisor, Clinical Pharmacology

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

📋 Description

• Provide clinical pharmacology and pharmacokinetics/pharmacodynamics (PK/PD) insights to project teams, aiding in decisions regarding dosage, patient demographics, and study design.

• Execute and analyze noncompartmental and population pharmacokinetic (PK) assessments for Phase 1–2 studies, encompassing first-in-human (FIH), single ascending dose (SAD)/multiple ascending dose (MAD), drug-drug interaction (DDI), food effect, organ impairment, and patient studies.

• Create structural models, assess covariates, and conduct model diagnostics.

• Develop and implement exposure–response and PK/PD analyses along with physiologically-based pharmacokinetic (PBPK) models to facilitate dosage selection and evaluate drug–drug interaction risks.

• Integrate nonclinical PK/PD data, in vitro absorption, distribution, metabolism, and excretion (ADME) information, and biomarker data to assist in human PK and dosage projections, interspecies scaling, and first-in-human justification.

• Compose PK/PD sections for clinical development plans, protocols, analysis strategies, investigator brochures, study reports, and regulatory documents including IND, CTA, NDA, and MAA submissions.

• Work collaboratively with drug metabolism and pharmacokinetics (DMPK), translational sciences, clinical development, bioanalysis, biostatistics, regulatory affairs, and project management teams.

• Oversee the daily scientific contributions of contract research organizations (CROs) and vendors.

• Engage in peer review of analyses and reports.

• Present findings to internal stakeholders and assist in external scientific publications and presentations.

⛳️ Requirements

• PhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or a related field, or a graduate degree in these disciplines with a strong work history.

• A minimum of 3 years of industry experience in clinical pharmacology or pharmacometrics within biotechnology, pharmaceuticals, or drug development settings; relevant postdoctoral experience is also considered.

• Comprehensive understanding of PK/PD theory, ADME, DDI mechanisms including in vitro-to-clinical translation, and model-informed drug development (MIDD) principles.

• Proficient with software tools such as NONMEM, Phoenix WinNonlin/NLME, Monolix, R, or similar platforms.

• Capable of selecting suitable analyses, troubleshooting model issues, and clearly articulating a model's assumptions and limitations.

• Familiarity with FDA, EMA, and ICH guidelines pertinent to clinical pharmacology, including ICH M12 and ICH M15.

• Interest in translational medicine, focusing on target engagement, biomarkers, and the translation from nonclinical to clinical settings.

• Ability to thrive in cross-functional, matrixed environments.

• Exceptional communication and stakeholder management abilities.

• Experience with PBPK platforms such as Simcyp, GastroPlus, or PK-Sim, or in quantitative systems pharmacology (QSP) modeling is advantageous.

• A curious mindset, enthusiasm for the field, adaptability, strong problem-solving skills, a growth-oriented perspective, and an interest in artificial intelligence and digital innovation.

🏝️ Benefits

• Company bonus contingent on both individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical coverage.

• Dental insurance.

• Vision insurance.

• Prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, which include an employee assistance program, fitness incentives, and various employee clubs and activities.

• Employee resource groups available to all employees.