Agenus
Global Head, Clinical Pharmacology, I/O Clinical Development
Agenus, Lexington, Massachusetts, United States, 02173
The role:
As the Head of Clinical Pharmacology, you will have responsibility and accountability for clinical pharmacology and pharmacometric programs at Agenus. You will have unparalleled opportunity for involvement throughout the entire drug development process; from preclinical studies, first-in human trials, and registrational trials, through approval and post-marketing activities, you will support the development of a robust portfolio of immunotherapy products.
In the role you will:
Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for small/large molecule drug developmentStrong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (NCA, population modelling, PK/PD, literature meta-analyses, exposure-response analyses etc)Application of physiologically-based pharmacokinetic (PBPK) modeling analysis to support dose decisions in clinical trials and simulation of drug-drug interactions for quantitative risk assessment is a plus.In-depth knowledge and expertise with modeling and simulation software programs such as (NONMEM, R, S-Plus, Monolix, SimCYP, GastroPlus. Etc.)Independently runs pharmacology trials that are of higher complexity both in scope and volume.Manages timelines and assists in budgets to insure prompt and accurate execution of clinical studies.Analyzes complex problems in component parts and to identify causal relations.Demonstrates a strong understanding of applied medicine.Anticipates problems that may occur in clinical trials and develop solutions for them using precedents or original thinking.Conducts clinical pharmacology studies in line with clinical PK and product development strategies.Designs and works with CRA regarding implementation and conduct of clinical pharmacology studiesAnalyzes, interprets, and writes reports for clinical and regulatory submissions.Ensures the quality of patient care and adherence to scientific, safety and regulatory standards.Assists with managing timelines and budgets to insure prompt and accurate execution of clinical studies.Assists in the implementation of the Phase I/II clinical development plans for complex product development strategies.Designs and works with CRA and CTM management regarding implementation and conduct of clinical pharmacology studies.Directs clinical pharmacology activities and resources, for both internal and external contractors/vendors.Responsible for planning and conducting clinical pharmacology studies and leading multiple study teams.Oversees study related activities and resources, both internal and with external contractors/vendors.Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programsContributes to and represents department on multifunctional project teams.Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required.Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing.Qualifications: About You
10 years of experience PhD or PharmD degree in pharmacokinetics or a related scientific discipline.A minimum of 5 years in oncology drug development in immunotherapy.Prior regulatory experience also preferred.
As the Head of Clinical Pharmacology, you will have responsibility and accountability for clinical pharmacology and pharmacometric programs at Agenus. You will have unparalleled opportunity for involvement throughout the entire drug development process; from preclinical studies, first-in human trials, and registrational trials, through approval and post-marketing activities, you will support the development of a robust portfolio of immunotherapy products.
In the role you will:
Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for small/large molecule drug developmentStrong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (NCA, population modelling, PK/PD, literature meta-analyses, exposure-response analyses etc)Application of physiologically-based pharmacokinetic (PBPK) modeling analysis to support dose decisions in clinical trials and simulation of drug-drug interactions for quantitative risk assessment is a plus.In-depth knowledge and expertise with modeling and simulation software programs such as (NONMEM, R, S-Plus, Monolix, SimCYP, GastroPlus. Etc.)Independently runs pharmacology trials that are of higher complexity both in scope and volume.Manages timelines and assists in budgets to insure prompt and accurate execution of clinical studies.Analyzes complex problems in component parts and to identify causal relations.Demonstrates a strong understanding of applied medicine.Anticipates problems that may occur in clinical trials and develop solutions for them using precedents or original thinking.Conducts clinical pharmacology studies in line with clinical PK and product development strategies.Designs and works with CRA regarding implementation and conduct of clinical pharmacology studiesAnalyzes, interprets, and writes reports for clinical and regulatory submissions.Ensures the quality of patient care and adherence to scientific, safety and regulatory standards.Assists with managing timelines and budgets to insure prompt and accurate execution of clinical studies.Assists in the implementation of the Phase I/II clinical development plans for complex product development strategies.Designs and works with CRA and CTM management regarding implementation and conduct of clinical pharmacology studies.Directs clinical pharmacology activities and resources, for both internal and external contractors/vendors.Responsible for planning and conducting clinical pharmacology studies and leading multiple study teams.Oversees study related activities and resources, both internal and with external contractors/vendors.Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programsContributes to and represents department on multifunctional project teams.Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required.Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing.Qualifications: About You
10 years of experience PhD or PharmD degree in pharmacokinetics or a related scientific discipline.A minimum of 5 years in oncology drug development in immunotherapy.Prior regulatory experience also preferred.