Incyte
Clinical Pharmacology Director
Lead and oversee clinical pharmacology activities on project teams, advancing drug candidates from IND through Phase IV. The role serves as the PBPK subject matter expert, collaborating with cross-functional stakeholders to inform dose selection, formulation strategy, drug-drug interaction risk assessment, organ impairment strategy, pediatric extrapolation, and regulatory submissions.
Key Responsibilities
- • 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.
- • Liase 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.
- • 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.
Required
- • 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.
- • 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).
- • Ability to prioritize and manage multiple projects while meeting project deadlines.
Preferred
- • 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.
- • 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
Overview
Clinical Pharmacology Director
We are seeking a Clinical Pharmacologist with expertise in Physiologically Based Pharmacokinetic (PBPK) modeling within the Clinical and Quantitative Pharmacology (CQP) organization in Translational 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
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Clinical Pharmacology Director
We are seeking a Clinical Pharmacologist with expertise in Physiologically Based Pharmacokinetic (PBPK) modeling within the Clinical and Quantitative Pharmacology (CQP) organization in Translational 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.
- Liase 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
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