Senior Investigator (Associate Director) in DMPK
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.
We are seeking a Senior Investigator (Associate Director) in the Metabolism and Pharmacokinetics (MAP) organization at the Genomics Institute of Novartis Research Organization (GNF) to contribute to the discovery and development of novel therapeutics. The successful candidate will represent the MAP organization while working across research and development governance bodies, collaborating with other disciplines on solutions to drug-discovery problems and ensuring project needs are met. He/She would also be expected to provide guidance and mentorship to others in areas of metabolism, pharmacokinetics and other areas of drug discovery and development.
• As a PK Project Team Member (PTM), this individual will design strategy and coordinate pharmacokinetic/pharmacodynamics (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.
• Support the efficient application and integration of DMPK and ADME studies to advance lead optimization and clinical candidate selection. Modalities include small molecules, therapeutic proteins, antibodies, antibody-drug conjugates (ADCs), and catabolites of antibody and protein conjugates.
• Represent the DMPK discipline on global cross-functional project teams while driving the design, execution, and analysis of DMPK and PK/PD.
• Serve as a primary source of scientific expertise for the design, analysis, reporting, and presentation of PK/PD modeling and safety studies.
• Bring innovative ideas and approaches that inform and influence the overall drug discovery and development process.
• Provide in-depth knowledge of drug-drug interactions, biotransformation, bioanalytical, and PK/PD modeling sciences.
• Collaborate with global PK Sciences to ensure an aligned position on human PK/PD projections as candidates transition into the clinic.
• Provide leadership to ensure scientific integrity of documents related to preclinical and clinical drug development process including Investigator Brochures, IND’s (or equivalent), protocols, and final study reports.
• Support DMPK components of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures. *Minimum requirements • Ph.D. in pharmaceutical sciences, DMPK or related disciplines with thorough knowledge of absorption, distribution, drug metabolism, pharmacokinetics, and PK/PD modeling
• Broad experience in working with cross functional project teams to support preclinical drug discovery and early clinical development
• Minimum 10 years of pharmaceutical industry experience including preclinical DMPK, PK/PD modeling, drug development , protocol/IB preparation support, regulatory interactions and submissions
• Demonstrated leadership and project management skills
• Familiarity and hands on experience with Phoenix WinNonlin, and/or NONMEM, GastroPlus etc. is a plus
• Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving.