Senior Medical Director
2 days ago
Mirum Pharmaceuticals is seeking a highly experienced Senior Medical Director to lead our Clinical Development team. As a key member of our organization, you will be responsible for overseeing all clinical trial-related activities across all stages of clinical development.
Key Responsibilities- Leadership and Management: Provide strategic leadership and management of complex, global development clinical study programs from phase 1 through post-commercialization.
- Medical Inquiries: Serve as the primary point of contact for medical inquiries from sites, CROs, and site monitors, ensuring timely and accurate responses.
- Clinical Operations: Collaborate closely with internal Clinical Operations teams for site selection, site start-up activities, study management, and closeout activities.
- Document Creation: Support the creation of and/or review of clinical slides for internal and external meetings, as well as author key clinical study documents.
- Medical Monitoring: Responsible for medical monitoring of efficacy and safety clinical trial data.
- Development Planning: Provide strategic input on the overall development plan, including internal and external evaluation of new indications and studies.
- Compliance and Inspection Readiness: Oversee medical aspects of compliance and inspection readiness in completed, ongoing, and starting clinical trials.
- Scientific Publications: Collaborate in the analysis and writing of scientific publications/presentations.
- Education/Experience: MD with a minimum of 5 years of experience, with a preference for experience in Liver or rare disease.
- Regulatory Knowledge: Knowledge and understanding of regulatory requirements for product approval and compliance in the US and Europe.
- Leadership Skills: Demonstrated accountability for delivery on complex development plans, leadership in clinical development programs, and experience with basic statistical principles and techniques of data analysis, interpretation, and clinical relevance.
- Communication Skills: Effective communicator with strong verbal and written skills, ability to identify issues, analyze situations, and provide effective solutions.
- Travel Requirements: Willingness and ability to travel domestically and internationally, with an anticipated 30% of work time dedicated to travel.
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