The Medical Director serves as the project physician and provides medical and scientific expertise to project teams, ensuring the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety.
Requirements
- Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement
- Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings.
- Write or edit scientific content of deliverables within budget and timelines.
- Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy
- Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts)
- Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications
- Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed
- Serve as a medical resource for study sites, the project team and clients
- Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions
- Assume responsibility for medical and safety monitoring on assigned projects
- Participate in feasibility discussions relating to specific project proposals
- Develop training modules and provide training concentrating on disease states
- Participate in process improvement activities
- Collaborate with Senior Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
