Sr. Specialist, Clinical Supplies – Peregrine Pharmaceuticals – Tustin, CA, USA
The Sr. Specialist, Clinical Supplies will be responsible for the design, set up and execution of timely, efficient and effective supply chains supporting multiple clinical trials. Responsibilities include various aspects of ensuring clinical supply including forecasting, manufacturing, inventory and distribution plans along with effective planning of clinical supplies to ensure timely study starts and ongoing re-supplies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage the planning, manufacturing and logistics of clinical material supply to support various clinical programs including multiple ISTs and late stage clinical trials
- Budget and manage costs associated with clinical supply management and distribution for clinical trials
- Coordinate and oversee clinical material packaging and labeling activities at third party vendors
- Develop clinical label and packaging requirements and specifications
- Develop distribution and return drug plans
- Lead comparator sourcing and planning activities
- Coordinate with Regulatory and Clinical Operations in ensuring clinical trial supply requirements and regulations are met
QUALIFICATIONS
We require a Bachelor’s degree in a scientific discipline with a minimum of 5 years of biotechnology or pharmaceutical industry experience working in a GMP environment supporting clinical cold chain drug supply activities. Additional required qualifications are as follows:
- Must have demonstrated experience leading clinical supplies planning and logistics activities for early and late stage global clinical trials
- Need experience developing and managing budgets and associated tracking of work versus invoices
- Experience in biologics based clinical supplies is essential
- Experience in label and packaging design development is highly desirable
- Experience working with IVR, IWRS, etc. is required
OTHER REQUIREMENTS
Occasional overnight travel by land and/or air may be required to attend meetings, out of state site visits, conferences, etc.
RELOCATION AVAILABLE
Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.
