Senior/Executive Medical Director
Role and Responsibilities
- Oversees the direction, planning, execution and interpretation of clinical trials/research and data collection activities
- Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports
- May recruit clinical investigators and negotiate study design and costs
- Responsible for directing human clinical trials, phases I – III, for company products under development
- Responsibilities also include adverse event reporting and safety responsibilities monitoring
- Coordinates and develops information for reports submitted to the FDA
- Monitors adherence to protocols and determines study completion
- May act as consultant/liaison with other corporations when working under licensing agreements
- Selects, develops and evaluates personnel to ensure the efficient operation of the function
- Develops corporate and/or organizational policies and authorizes their implementation
- Develops innovative concepts and promotes new ideas that support the company’s objectives and timelines
- Recognized as a strategic leader and influential people manager
- Consistently works with abstract ideas or situations across functional areas of the business and identifies and evaluates fundamental issues, providing strategy and direction
- Requires in-depth knowledge and understanding of the functional area, business strategies and company goals
- Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters
- Creates and implements department-related policies that affect the company as a whole, while ensuring compliance issues are met
- Makes final decisions on administrative or operational matters and ensures operations effective achievement of objectives
- Ensures that budgets and schedules meet corporate timelines
- Directs and controls the activities of one or more functional areas through senior managers who have overall responsibility for the successful operation of those assigned areas
Qualifications and Education Requirements
- MD required, US Board certified/ eligible medical oncologist
- 4+ years of biotech industry experience in therapeutics required
- Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development particularly in solid tumors
- Excellent leadership, teamwork and collaboration skills
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.