Senior Investigator, PK Sciences - NJ (Associate Director) job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D. |
The PK Sciences(PKS) Department at Novartis Institutes for BioMedical Research (NIBR) is recruiting for an accomplished degree-qualified scientist to negotiate an optimal PK/PD strategy for early and full development projects in the Oncology Diseases in liaison with line functions and management input, as appropriate. You will be responsible for the PK, PK/PD and Modeling & Simulation component of study protocols, reports, project summaries and development plans within agreed timeframes and in compliance with regulatory requirements. Furthermore, you will prepare appropriate regulatory responses to Health Authority inquiries (globally) and interpret and present project-related study results.• PhD in natural /biological sciences, DVM, PharmD or equivalent with biological background or equivalent training on the job. • Fluent English (oral and written). • Minimum 8 years in drug development with a minimum of 3 years of experience as Senior Project Team Representative (Global Project Teams or early development teams) within a relevant Line Function in industry or regulatory agency working on the PK/PD aspects. • Possesses a broad knowledge of overall drug development aspects outside own area of expertise. • Proven record as team player/leader with superior negotiation skills. • Ability to manage conflicting expectations in a matrix environment. • Excellent project management skills. • Excellent knowledge of drug development guidelines. • Ability to coach and advise colleagues in project related matters. • Managerial skills to provide input into performance plans and appraisal of Project Team Representatives and/or Senior Project Team Representatives. • People management skills (responsibility or co-responsibility for appraisal) in a matrix environment or for direct reports.