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Principal Investigator / Sr. Principal Investigator, Clinical Pharmacology & Pharmacometrics

Incyte · Wilmington, DE · 1 wk ago
On-siteFull-time

Job Summary (Primary Function)

We are seeking a Clinical Pharmacologist with expertise in Physiologically Based Pharmacokinetic (PBPK) modeling within the Clinical and Quantitative Pharmacology (CQP) organization in Transaltional Medicine. In this role, You will play a crucial role in leading and overseeing the clinical pharmacology activities on project teams. You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including quantitative pharmacology, in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs. You will also serve as the PBPK subject matter expert, partnering closely with, Clinical Development, DMPK, Drug Discovery, Pharmaceutical Sciences, Translational Medicine, Biometrics, Regulatory Affairs, and Drug Safety to inform critical development decisions.

Your work will influence dose selection, formulation strategy, drug-drug interaction risk assessment, organ impairment strategy, pediatric extrapolation, and regulatory submissions throughout the development lifecycle.

How You Will Contribute

  • Develop and implement the CP strategies across program, indication and study levels, including strategies for Phase I –III drug development.

  • Provide guidance in interpreting the data from quantitative pharmacology analyses, including PPK, exposure-response analyses, and other quantitative analyses, to drive MIDD based decision making for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.

  • Provide the clinical pharmacology components of clinical plans and provide clinical pharmacology expertise to the project team.

  • Liaise closely with biologists, DMPK, Pharmaceutical Sciences, Clinical Pharmacology, Translational Medicine, and Clinical Development to answer key mechanistic questions through innovative study designs and/or analyses.

  • Present data and recommendations to global program teams, external collaborators and senior management.

  • Build, verify, qualify, and apply PBPK models using platforms such as Simcyp, GastroPlus, PK-Sim, or equivalent software.

  • Integrate in vitro ADME, physicochemical, preclinical, and clinical data to develop mechanistic understanding of drug disposition.

  • Design and build PBPK and mechanistic models to assist with safety margin selection, study design and biomarker selection, including (but not limited to) first in human (FIH) predictions, formulation design/optimization, population simulations, pediatric extrapolation, and DDI predictions.

  • Knowledge in DDI is a must.

  • Interpret modeling results and communicate recommendations to multidisciplinary teams and senior leadership.

  • Author PBPK reports, regulatory documents, briefing books, and responses to health authorities.

  • Stay current with scientific advancements and regulatory trends in clinical pharmacology and Pharmacometrics, and apply the knowledge to advance drug discovery and development for the organization; Publish in peer reviewed journals.

  • Present work internally and externally through scientific communications and conference presentations.

Minimum Requirements/Qualifications

  • Ph.D. or MD with 3 to 10 years or more of experience in appropriate disciplines that lay the foundation for the job functions detailed above;

  • Prior successful experiences on clinical development teams delivering enabling clinical PK and clin pharm analyses;

  • Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process;

  • Strong competency in learning and running PBPK modeling and simulation related software such as GastroPlus, SimCyp, PKSim, R and Matlab/SimBiology.

  • Hands-on project experience in PBPK modeling and simulation through direct industry experience as well as knowledge of regulatory expectations regarding PBPK modeling is preferred.

  • Preferred hands on experience with PPK, ER or PBPK analyses and reporting, and experience using NONMEM, R, SimCYP or GastroPlus, or other programs.

  • Direct pharmaceutical or biotechnology industry experience supporting clinical development programs.

  • Experience interacting with FDA, EMA, PMDA, or other regulatory agencies regarding PBPK analyses.

  • Experience with model-informed drug development (MIDD).

  • Demonstrated a general understanding of general DMPK disciplines: in vitro ADME, pharmacokinetics, transporter, DDI, translational modeling, biotransformation, biomarker strategy is a plus.

  • Demonstrated publication record; lead/senior author contributions is a plus.

  • Ability to prioritize and manage multiple projects while meeting project deadlines.

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