Senior Investigator, PK Sciences (Associate Director) job in Cambridge
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
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 Senior Investigator, PKS (Associate Director) supports oncology drug development by providing DMPK and clinical pharmacology expertise across all development phases for their assigned projects. The major focus of this role may be in drug discovery or early clinical development. This individual represents the PKS global line function on cross-functional teams driving the design, execution, and analysis of DMPK and clinical pharmacology studies.
1) Support for the efficient application and integration of PK and ADME studies in support of clinical, candidate selection and lead optimization programs
2) Contributes 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.
3) Designs 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).
4) Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.
5) Ensures 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).
6) Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical and M&S aspects of development plans.
7) Monitors study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools. Assure rapid and effective communication of data to teams and management.
8) Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance).
9) Attends meetings with external parties including investigators, outside experts, and health authorities.Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent.
6+years of relevant post-doctoral, academic, industry or government experience. Expert knowledge of biologics and/or small molecule research and development (immunotherapeutics, ADCs) and/or in-depth knowledge of related disciplines (e.g., DMPK, organic chemistry, Oncology, translational medicine, biostatistics, toxicology, regulatory) in the drug development process. Experience with pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp) is strongly preferred. 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.