Job Description A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. Under the umbrella of the Novartis Institutes for Biomedical Research (NIBR), the Genomics Institute of the Novartis Research Foundation (GNF) located in La Jolla, California, has the support of a broad collaboration with the entire Novartis research organization, while maintaining the independence to initiate and drive independent research programs.
Position title: Investigator III, DMPK
We are seeking an Investigator III scientist to join the Metabolite and Pharmacokinetics (MAP) organization at the Genomics Institute of Novartis Research Organization (GNF). He/she will support preclinical drug discovery and development with expertise in the pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME). The qualified candidate will represent the department at discovery working group meetings, suggest and implement strategies and tactics to address PK/PD/ADME related issues and ultimately enable program decision-making in the selection and advancement of high-quality drug candidates from discovery into development.
• As a PK Project Team Member (PTM), this individual will design strategy and coordinate PK/PD and drug metabolism related studies for preclinical projects in a variety of disease areas including oncology, immune-oncology, metabolic diseases and regenerative medicine.
• Represent the DMPK discipline on global cross-functional project teams while driving the design, execution, and analysis of DMPK and PK/PD.
• Support the efficient application and integration of DMPK and ADME studies to advance lead optimization and clinical candidate selection.
• Demonstrate in-depth understanding of all aspects of DMPK with special emphasis on the application of pharmacokinetics in drug discovery and the ability to work in a team-based drug discovery/development environment.
• Provide in-depth knowledge of drug-drug interactions, biotransformation, bioanalytical, and PK/PD modeling sciences.
• Serve as a primary source of scientific expertise for the design, analysis, reporting, and presentation of PK/PD modeling and safety studies.
• Knowledge and experience with the design of experiments to define PK/PD relationships and competency using non-compartmental and compartmental techniques as well as pharmacokinetic modeling software (e.g. Phoenix Winnonlin or equivalent)
• Bring innovative ideas and approaches that inform and influence the overall drug discovery and development process.
• Make use of PK resources across the GNF and NIBR organizations to drive drug discovery efforts; collaborate with global PK Sciences to ensure an aligned position on human PK/PD projections as candidates transition into the clinic.
• Support DMPK components of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements
• Ph.D. in pharmaceutical sciences, DMPK or related disciplines with thorough knowledge of clinical pharmacology, absorption, distribution, drug metabolism, pharmacokinetics, and PK/PD modeling.
• Minimum 5 years of pharmaceutical industry experience including preclinical DMPK, PK/PD modeling, drug development, protocol/IB preparation support.
• Experience with LMW molecule drug discovery is required, experience with large molecules/biotherapeutics is a plus.
• Familiarity and hands on experience with Phoenix Winnonlin and/or GastroPlus
• Excellent commun