Director of Clinical Development
The Director of Clinical Development is a full-time position, to which you would devote substantially all of your professional effort, reporting to the Chief Medical Officer. You would be primarily responsible for all clinical development and clinical affairs operations activities with responsibility for developing and implementing the overall clinical research strategy through functional interaction with Research and Development team and other senior management. Principal responsibilities include:
- Management and oversight of all clinical study activities,
- Recruit and manage clinical research associate, program manager(s) and database manager team members and other relevant staff as it relates to clinical operations,
- Mentors and develops Clinical Affairs staff. Directs internal staffing and performance management, including hiring, training, coaching and performance reviews.
- Participate in regulatory strategy and matters especially as they pertain to clinical development activities, in close collaboration with Regulatory Affairs
- Oversee clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment,
- Establishes and approves (with outside vendor, Executive team, biostatistics group) scientific methods for design and implementation of clinical protocols, data collection systems and final reports
- Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, white papers and assist with manuscript preparation,
- Creates and directs program/project-related advisory committees as needed, DSMB and/or expert consultants
- Forecasting of clinical activities and assist in developing clinical operational budget,
- Assist in developing clinical strategy for Company to advance product development, launch, and adoption,
- Establish and maintain excellent partnerships with contractors, vendors, CROs, and internal team members,
- Guide development of in-house operations SOPs, guidelines and systems,
- Travel to clinical sites when needed for site recruitment and review and meetings both domestic and international,
- Keep company officers well informed of progress, problems and opportunities; provides weekly enrollment and program updates to senior management.
- Ensures that Clinical Affairs department effectively interfaces with key functional groups.
- Other matters as may be determined by yourself and the Company.