The candidate will use their immunology knowledge and will master the molecular immunological techniques including molecular cloning, retroviral transduction, siRNA, western blotting, immunoprecipitation, PCR, RT-PCR.
This position will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
As a Clinical Affairs Scientist, your main responsibilities will be to determine clinical strategy in conjunction with team members, write clinical protocols, analyze data and write reports to support the clinical documentation of Companion Diagnostics (CDx)in the field of tissue-based Cancer Diagnostics.
The successful candidate will execute clinical pathology assays, interact with discovery scientists, pathologists, and toxicologists to deliver excellent data supporting advancement of the R&D pipeline of therapeutic candidates across major therapeutic areas such as oncology, cardiometabolic disorders, inflammation and neuroscience.
The primary responsibilities include, but are not limited to: designing complex quantitative pathology assays, and implementing new technologies to address key questions about our therapeutic candidates.
The individual will be responsible for the designing, planning and execution of clinical pharmacology strategies & studies in support of development of small and large molecule drugs & cutting-edge novel modalities.
The successful candidate is expected to work cross-functionally within the company and to interact closely with both the clinical and discovery research groups. The position will focus on assay development and qualification across multiple platforms.
Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies. In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct/metrics (enrollment, GCP practices, handling of safety issues, etc.)
The Clinical Research Associate (CRA) conducts site monitoring responsibilities for Clinical trials, according to Covance Standard Operating Procedures, ICH guidelines and GCP, including Pre-study, Site Initiation, Routine Monitoring, and Close-out Visits.