Clinical Research Medical Director - Cardiology/Heart Failure, US - Remote

View full description

Requirements:

• MD or DO degree from an accredited medical school.
• Minimum of 2 years of clinical research experience and/or basic science research.
• Preferred 5 years of experience in late clinical development within a pharmaceutical organization.
• Strong clinical development experience in cardiology or relevant sub-specialty.
• Knowledge of pharmaceutical product development and commercialization processes.
• Experience developing clinical study concepts and trial designs.
• Knowledge of Good Clinical Practices (GCP), FDA, and relevant international regulations.
• Leadership experience in a complex matrix environment.
• Ability to present complex medical concepts effectively.

Responsibilities:

• Provide clinical/scientific knowledge into the development and execution of the global evidence generation plan for the AMG 133 phase 3 program.
• Support cross-functional and global collaborations to integrate medical, scientific, and commercial input.
• Participate in safety and regulatory interactions and provide clinical trial data interpretation.
• Author clinical study reports and regulatory submissions.
• Develop key opinion leaders and present at advisory boards.
• Provide clinical content input to scientific and commercial materials.
• Contribute to TPP and Global Product Safety development.
• Create development options for the Global Dev Review Committee.