Senior Director – Medical Monitor, Immunology/Rheumatology
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Job Description
Medical Monitor overseeing clinical studies and providing medical oversight in drug development. Collaborate with teams and customers to ensure the integrity of projects and subject safety.
Responsibilities:
- Provides medical oversight of assigned clinical studies in the duty as a medical monitor
- Often serves as primary medical contact for customers for assigned clinical studies
- Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
- Responsible for protocol design and development, upon request
- Provides input into protocol amendments
- Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
- Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
- Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data
- Represents the Company at scientific and industry meetings
- Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area
Requirements:
- Provides medical oversight of assigned clinical studies in the duty as a medical monitor
- Often serves as primary medical contact for customers for assigned clinical studies
- Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
- Responsible for protocol design and development, upon request
- Provides input into protocol amendments
- Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
- Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts
- Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
- Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines
- Represents the Company at scientific and industry meetings
Benefits:
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
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