Description
Syneos Health is seeking a Senior Medical Director to provide medical and safety oversight of clinical studies. The successful candidate will interact with customers, provide training and support to project teams, and ensure subject safety and scientific integrity of clinical studies.
Responsibilities:
- Provide medical oversight of assigned clinical studies as a medical monitor
- Provide therapeutic input and consultation to customers for assigned clinical studies
- Develop and deliver project-specific and therapeutic training to project team members and clinical site staff
- Provide medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts
- Provide medical input into data collection tools, monitoring plans, and review and analysis plans
- Oversee assigned Medical Scientist staff and Medical Director colleagues to review clinical data
- Contribute to the development of product/clinical development plans
- Collaborate with customer and internal colleagues regarding other reports, applications, and regulatory submissions
- Locate and engage external experts/consultants/advisors as necessary
- Provide medical input and oversight in support of the Drug Safety and Pharmacovigilance department
- Provide after-hours medical coverage for clinical studies
Qualifications:
- Degree in medicine and significant clinical experience in the practice of medicine in specific therapeutic area
- Significant clinical research and demonstrated leadership experience
- Expert knowledge of drug development process, regulatory policies and procedures
- Excellent written and verbal communication skills
- Prior leadership experience required
- Strong understanding of the use of medical terminology and of drug-names in multiple nations and environments
- Demonstrated ability to lead and excel in a matrix environment
- High degree of proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
- Ability to handle multiple priorities to meet deadlines in a dynamic environment
- Fluency in written and spoken English is essential