6500! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
PK Sciences (PKS) is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of NIBR. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise organization, working across both NIBR and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.
The Senior Investigator, PKS Oncology supports oncology biologics drug discovery and development by providing DMPK and clinical pharmacology expertise.The major focus of this role will be in drug discovery for biologics modalities. This individual represents the PKS global line function on cross-functional teams driving the design, execution, and analysis of DMPK and clinical pharmacology studies.
In this role you will:
Support for the efficient application and integration of PK and ADME studies in support of clinical, candidate selection and lead optimization programs
Contribute expert pharmacokinetic / DMPK input into key pre-clinical, clinical and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager.
Design clinical pharmacology strategy for assigned program and coordinates pharmacokinetic / DMPK related elements for projects. Identifies potential project hurdles, suggests solutions and establishes contingency plans. Represent TCO Clinical Pharmacology on Early Project Teams (EPTs).
Ensure constructive collaboration within EPTs and with other internal business partners including, Global Discovery Chemistry, Preclinical Safety, Technical Research and Development, Biostatistics and Data Management, Drug Regulatory Affairs, and Modeling and Simulation (M&S).
Ensure constructive collaboration within EPTs and with other internal business partners including, Novartis Biologics Center, Preclinical Safety, Technical Research and Development, Biostatistics and Data Management, Drug Regulatory Affairs, and Modeling and Simulation (M&S).
Define, update and perform as appropriate the PK, PK/PD, DMPK biopharmaceutical and M&S aspects of development plans.
a PhD in natural /biological sciences, DVM, PharmD or equivalent with biological background or equivalent training on the job.
a minimum of 8 years drug discovery experience with at least 3 years of experience as Senior Project Team Representative (Global Project Teams or early development teams) within a relevant Line Function in industry working on the PK/PD aspects.
Extensive knowledge of biologics (e.g., monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, etc.) drug discovery with demonstrated experience in guiding the PK/PD and bioanalytical strategy for selection of clinical candidates; knowledge of protein engineering practices is preferred
Knowledge and experience in either oncology, immunology, and/or tumor immunology are desired.
Working knowledge of PK/PD software (e.g., WinNonlin, NONMEM, ADAPT II, SimBiology, etc) and the ability to analyze and critically assess PK/PD data is essential.
A proven record as team player/leader with superior negotiation skills with the ability to manage conflicting expectations in a matrix environment. Excellent project management skills.
the ability to coach and advise colleagues in project related matters. 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.