Job Description
An experienced Senior Medical Director is sought to lead clinical trials from Phase I to Phase III, focusing on data integrity, patient safety, and regulatory compliance. This strategic role requires a senior physician with extensive experience in clinical research, preferably within immunology or SLE.
Key Details:
* Clinical Study Leadership – Act as the medical representative of the Clinical Study Team (CST), overseeing all medical aspects of clinical trials.
* Medical Oversight – Monitor patient safety and data integrity, following ICH-GCP and internal standards as outlined in the Medical Monitoring and Oversight Plan.
* Responsibilities
o Review patient data, CRFs, data listings, and study documents (protocols, SAPs, ICFs, IBs, IMPDs).
o Provide medical input on CRO/vendor selection, and work closely with CROs and key opinion leaders.
o Train investigators, CRAs, and vendors, and act as a central point of contact for medical study-related questions.
o Participate in the Safety Management Team, assess and mitigate safety risks, and contribute to CAPA development and protocol deviation management.
o Support regulatory submissions and external communication of results, including CSR review and publications.