Currently looking for an experienced Investigational Drug Pharmacist for the Director of Investigational Drug Services opening at City of Hope National Medical Center. Interested candidates must have a minimum of 5 years of experience in Oncological Investigational Drugs as well as a minimum of 3 years of leadership experience.
Responsibilities of the Director Investigational Drug Services
- The Director of the Investigational Drug Service (IDS) oversees operation of all investigational drug services, including coordination of distribution activities, clinical practice, performance improvement, regulatory compliance for medication management, and system improvements for medication safety.
- This position plays a key role in enhancing the reputation and service-orientation of City of Hope’s clinical research program by providing expertise in support of clinical investigational drug trials.
- Plans, directs, coordinates and leads Investigational Drug Services (IDS) Program to achieve service, quality, medication safety and study activation goals that contribute to the overall success of COH.
- Accountable for a safe and effective process for Research medications including IDS role in SRO creation, approval of individual patient’s SRO for therapy and the support of key research activities including disease teams and IRB.
- Ensures investigational drug-related activities meet all licensing and regulatory requirements.
- Direct the pharmacy operations to generate revenue, minimize costs, assure compliance with applicable regulations and standards and achieve department objectives.
- Improve quality, streamline processes and minimize costs related and adverse outcomes through multidisciplinary approach.
- Provide pharmaceuticals in an accurate, timely and cost effective way. Provide pharmacist and physician leadership with drug utilization trends to identify where guidelines need to be developed.
- Ensure communication with Principal Investigators, Clinical Research Staff , Nursing staff regarding pharmacy services in the provision of quality patient care.
- Ensure adequate staffing of qualified and motivated employees who work as a team and are responsive to our patients, other department and the mission of City of Hope.
- Specific responsibilities include Patient Safety & Regulatory compliance (FDA, CDPH, CMS, TJC, Board of Pharmacy, DEA, and others) in relation to investigational/research drugs, process improvement and strategic planning for Research Drug processes.
- Oversight of computer research drug accountability software system and involvement as needed in the development or improvement of other Research-related computer systems.
- Primary pharmacy oversight of investigational drug studies including Phase 1 through Phase 4 trials.
- Work with COH Leadership, Research Leadership, MD’s, Nursing Leadership and key committees to promote a safe and effective Research medication distribution system.
- Facilitate rapport between the Department of Pharmacy, principal investigators, clinical trial coordinators, research assistants and trial sponsors.
- Liaise with external agencies/organizations, as required.
- Attract, retain, and develop a quality Pharmacy Staff/Management Team with appropriate feedback and evaluation.
- Supervise and provide direction to technical/support staff.
- Delegate work assignment and quality checks work. Provide technical and procedural guidance.
- Develop, gain approval, and achieve program operational plans in concert with Research Leadership; manage operational & capital budgets plans related to Investigational Drug Service to remain compliant with laws, regulations, and contractual terms.
- Service quality through effective planning, leadership and teaching; ensure compliance with regulatory and accreditation standards.
- Attend and contribute to interdisciplinary team meetings relating to clinical investigational drug trials.
- Monitor pharmacy activities, on a daily basis, to ensure adherence to proper inventory record maintenance and timely and accurate billing as required to support the clinical investigational drug trials.
- Maintain responsibility for clinical investigational drug trials.
- Review and understand complex protocols to ensure a safe storage and distribution of non-FDA approved medications and devices.
- Ensure resources are available for protocol review for safety and feasibility.
- Act as liaison with principal investigators and/or trial coordinators/research assistants to establish IDS’s role, determine fee schedules and to implement dispensing, compounding and billing procedures.
- Communicate with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial.
- Assist in ensuring the participation of the pharmacy department in all clinical trials which involve drugs/devices.
Requirements of the Director Investigational Drug Services
- Doctor of Pharmacy Degree (PharmD).
- 3 years of progressively responsible leadership experience and 5 years experience with investigational drug process.
- Previous experience in a major academic hospital setting.
- Knowledge & understanding of Human Subjects Research which includes the entire IRB application process, the legal requirements and oversight (OHRP, FDA, and others) and auditing/reporting results.
- Knowledge & understanding of Title 22, GMP, CDPH, CMS, HIPPA, California Pharmacy Law, provider regulations & Joint Commission Standards.
- Ability to utilize relevant computer systems.
- Quantitative skills for statistical analysis and budget assessment.
- Experience or affiliation with a teaching institution.
This is a management position
This is a full-time position