Merck
Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Rem
Merck, Helena, Montana, us, 59604
Merck Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (Remote)
We are seeking an experienced talented scientist to join the
Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO)
team in the role of Director. The QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to the development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.Primary Responsibilities:Serving as an expert representative for QP2-IO on Oncology development teams.Framing critical questions and strategy for optimizing model-based analyses on programs.Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, and quantitative systems pharmacology (QSP) modeling into programs, thereby strengthening our pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.Minimum Qualifications:Ph.D. with at least four years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.Masters, with or without PharmD, or equivalent degree with at least six years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.Required Experience:Demonstrated impactful experience with applications of pharmacometrics methods.Experience in IND, NDA and other submissions to global regulatory agencies.Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.Proficiency in R, NONMEM or other similar programming language.Professional working proficiency in written and verbal communication.Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Remote WorkShift:
1st - Day
#J-18808-Ljbffr
We are seeking an experienced talented scientist to join the
Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO)
team in the role of Director. The QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to the development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.Primary Responsibilities:Serving as an expert representative for QP2-IO on Oncology development teams.Framing critical questions and strategy for optimizing model-based analyses on programs.Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, and quantitative systems pharmacology (QSP) modeling into programs, thereby strengthening our pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.Minimum Qualifications:Ph.D. with at least four years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.Masters, with or without PharmD, or equivalent degree with at least six years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.Required Experience:Demonstrated impactful experience with applications of pharmacometrics methods.Experience in IND, NDA and other submissions to global regulatory agencies.Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.Proficiency in R, NONMEM or other similar programming language.Professional working proficiency in written and verbal communication.Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Remote WorkShift:
1st - Day
#J-18808-Ljbffr