SItuation:
Company with targeted therapies in all stages of clinical development in oncology. Operational strategy was to scale capabilities to manage development programs in-house in preparation for an initial public offering. There were scientists and physicians on board but little business operations to support development.
Solutions:
Conducted a Gap Analysis, then implemented the following to close the gaps over a one year period:
- Interim leadership in Clinical Operations Group and program oversight of seven studies: selected, contracted and managed 20+ vendors (CROs and specialty labs); led all program start up activities; tracked study-related operational activities (program updates, timelines, and budgets); and instituted reporting of study progress to CEO.
- Supported due diligence activities for a potential acquisition
- Represented clinical in an alliance with a global pharmaceutical company.
- Defined job descriptions, roles and responsibilities, and interdepartmental processes for vendor selection, contracting, budgeting and communications.
- Created and implemented Quality System to provide a framework for organizational growth.
- Developed and managed the authoring of protocols for upcoming studies.
- Identified, hired and transitioned to full time employees upon completion of activities.
Value:
Brought development organization beyond start up through implementation of scalable processes and systems to successfully implement multiple studies in a development program.