The Vice President Clinical Operations is responsible for the leadership, oversight and execution of clinical trials ensuring they are completed according to timelines, budgets and regulatory/corporate quality standards. The Vice President will serve as a functional leader, line manager and subject matter expert for the internal and field based Clinical Operations team. The incumbent will work collaboratively with other senior/functional leaders in the achievement of departmental and corporate objectives and initiatives. With extensive industry knowledge and experience, the Vice President will proactively seek to improve the efficiency, effectiveness and quality of Spectrum’s clinical trial activities. The incumbent will ensure all clinical studies are conducted in accordance with company SOPs, GCPs and ICH guidelines.
RESPONSIBILITIES:
- Accountable for the successful execution of Spectrum’s clinical trials ensuring they are conducted within timelines, budget and regulatory/corporate quality standards.
- Develop efficient resourcing plans for all trials ensuring open headcount positions are identified and filled expeditiously with qualified individuals.
- Recruits, motivate and manage all clinical operations staff including CTM to insure professional development and training of a high performing team.
- Identify outsourcing needs and oversee the selection, management and performance of CROs, vendors and external consultants.
- Accountable for the Clinical Operations budget, forecasting and management of functional/trial budgets.
- Develop and maintain strong, positive collaborations with other functional leaders.
- Implement a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.
- Develop and implement clinical monitoring training program to include GCP, monitoring and site management skills, and protocol-specific training (in collaboration with Medical Monitor).
- Establish quality processes within Clinical Operations that focus on data integrity and patient safety.
- Lead responses to audits (site, internal file and process, and regulatory agencies)
- Develop and execute staffing plans to ensure adequate and appropriate monitoring of all Spectrum-monitored trials.
- Serve as the functional representative during BIMO inspection readiness activities and during on-site regulatory audits/inspections.
- Oversee Quality Incident reporting activities and resolution of CAPAs related to the conduct of clinical trials.
- Lead the development and optimization of processes for Clinical Operations (SOPs). Proactively assess the need for new/updated processes and implement process improvement initiatives.
- Actively participate in the development of critical study documents such as protocols, Investigator Brochures, Clinical Study Reports etc.
- Provide accurate, current reports to senior leadership related to the status of clinical trials (monthly, quarterly as needed).
Required Skills
- A Bachelor’s Degree in a relevant field preferably Biological / Life Sciences or equivalent experience. Higher degree preferred.
- Strong working knowledge of GCP/ICH guidelines.
- Experience managing and mentoring internal and external resources.
- Experience in developing and managing departmental/study budgets and timelines.
- Strong interpersonal skills with demonstrated ability to effectively work with internal cross- functional groups.
- Extensive knowledge of other related drug development functions.
AVAILABILITY:
- Must be available to work in the evenings and weekends, as required.
POSITION LOCATION AND/OR TERRITORY AND TRAVEL:
- Position is currently based in Irvine, CA or Cambridge, MA
- Position may require occasional travel.
SPECTRUM PHARMACEUTICALS is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.
Required Experience
- Twenty years Clinical Operations experience with preferred background in hematology/oncology.
- Fifteen years in a clinical operations people management role.
- Global experience in both early and late phase clinical trials.
- Experience in managing multiple projects and priorities.