The Senior Manager, Clinical Sciences applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development, implementation and dissemination of clinical studies. The primary objective and purpose of this position is to ensure that clinical trials are designed to meet the regulatory and business needs of the responsible Business Unit and that study documents (i.e., protocols, study reports) are developed with scientific rigor. He / she leads others in all aspects of clinical science including research, developing and writing study protocols, investigator brochures, study summaries, clinical study reports, or other clinical documents. Additionally, he / she and team will assist Medical Affairs in Business Units in developing clinical strategies and executing publication strategies. The Senior Manager, Clinical Sciences will review study protocols as requested or required and may be asked to respond or provide guidance regarding scientific and related procedural issues from investigators. He / she will oversee one or more medical writers who will provide timely and accurate completion of medical writing deliverables.
The position works closely with Medical Affairs at Business Units, Principal Investigators and statisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc.
Additionally, he/she will collaborate and facilitate discussions with internal partners such as Health Economic & Outcomes Research, Global Health, Digital Health and others.