Pharmacokinetics Scientist, Oncology Clinical Pharmacology

Organization
Novartis Pharmaceuticals
Job Location
Cambridge, MA
Job Description

Novartis Oncology has an outstanding opportunity for a pharmacokinetics expert in our Clinical Pharmacology group supporting Research and Early Clinical Development for Biologics (antibodies, bispecifics and antibody drug conjugates). This is a great opportunity to collaborate with an exceptionally talented team of scientists and clinicians applying quantitative approaches to further our understanding of human pharmacology of different biologic formats targeting tumor cells and immune effector.
The Senior Scientist/Fellow (Manager)/Senior Fellow (Associate Director) Clinical Pharmacology will provide clinical pharmacology/DMPK expertise for their assigned projects. This individual will represent the Oncology Clinical Pharmacology global line function on cross-functional teams driving the design, execution, and analysis of DMPK and Clinical Pharmacology studies.

Responsibilities

1) Develop Clinical Pharmacology strategy for assigned program(s).
2) Coordinate, execute and deliver DMPK related elements for the project(s).
3) Advise research teams on non-clinical and clinical pharmacology, PK and PK/PD study design.
4) Perform or oversee PK and PK/PD analyses using a variety of tools and approaches.
5) Integrate, interpret and report data to teams, customers and management in a timely manner.
6) Identify potential project hurdles, suggest solutions and establish contingency plans.
7) Represent Clinical Pharmacology on Research and Early Development Project Teams.
8) Ensure constructive collaboration with the project team and internal business partners.
9) Prepare and update development plans.
10) Provide expert input into regulatory documents within agreed timelines
11) Maintain and enhance technical and drug development expertise.

Requirements: 
Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent.

Senior Scientist
0-5 years of relevant academic, industry or government experience.
Proficiency with pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp). Knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process. Ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment. Strong oral and written communication skills. Strong organizational and project skills. Critical thinking and problem solving skills. 
Manager
3-7 years of relevant post-doctoral, industry or government experience.
Experience with biologics research and development and/or in-depth knowledge of pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp). Strong knowledge of related disciplines (e.g., DMPK, Oncology, translational medicine, biostatistics, toxicology, regulatory) in the drug development process. Demonstrated ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment. Strong oral and written communication skills. Strong organizational and project skills. Strong critical thinking and problem solving skills, including publications/presentations.

Associate Director
6-10 years of relevant post-doctoral, academic, industry or government experience.
Expert knowledge of biologics research and development (immunotherapeutics, ADCs) and/or expert knowledge of pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp). Expert knowledge of related disciplines (e.g., DMPK, Oncology, translational medicince, biostatistics, toxicology, regulatory) in the drug development process. Demonstrated experience and ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment. Excellent oral and written communication skills. Strong organizational and project skills. Excellent critical thinking and problem solving skills, including publications/presentations. Strong influencing and negotiating skills. Coaching, mentoring, and people management skills. 

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