and develop new scientific approaches to meet the needs of customers. Knowledge of treatment guidelines, clinicalresearch... processes, FDA regulations, OIG guidelines and research or clinical experience in the management of pain and/or rheumatic...
etc. Closely partner with clinical pharmacologist, pharmacometricians, research, clinical, non clinical modelers and other relevant... R&D functions. Work closely with research and clinical functions to identify and interpret preclinical and clinical data...
is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned...
strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health... required. Executive level experience in a multi-facility/matrix management healthcare system strongly preferred Proven competence...
, compliance and regulatory matters in ClinicalResearch Experience in cross-functional interactions and working within a global... of agreements including creating assignment notices for the various agreement types including Clinical Study Agreements...
of medical accountability and oversight for multiple clinical trials Matrix management responsibilities across the internal... development protocols in a matrix team environment working with Clinical Scientists (CS) Partners with CS to support executional...
requirements into information system needs for clinical, teaching, and research systems. These systems must be designed to support... for major clinical information systems such as the EHR. Participates in applicable clinicalresearch as interest...
Care, business legal or scientific discipline preferred. At least 3 years of ClinicalResearch, business and/or contract... in ClinicalResearch Experience in cross-functional interactions and working within a global environment is an advantage. Proven...
in clinicalresearch in chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered Experience.... Job Description Senior Director, Clinical Development- Inflammation/Fibrosis (MD) POSITION OVERVIEW: As Senior Director of Clinical...
or equivalent) with a minimum of 2 years of pharmacovigilance experience or other relevant experience (e.g. Clinicalresearch... of assigned Janssen products and will strategically lead cross-functional matrix teams responsible for product safety and benefit...