Senior Clinical Supply Project Manager (Bay Area, CA)
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Clinical Supply Management (CSM) is a part of the Clinical Drug Supply Management (CDSM) organization within R&D Development Sciences. CSM is responsible for the management, planning, packaging, labeling, and distribution of investigational products and clinical trial materials to support all AbbVie Phase I to Phase IV studies, along with Investigator Initiated Studies and Compassionate Use situations.
Major Job Responsibilities
- Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity
- Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
- Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
- Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
- Develops protocol specific labeling compliant with applicable global regulations.
- Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
- Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
- Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages
- Bachelor’s Degree required, preferably in physical science, math, engineering, or pharmacy
- 5- 8 years total experience in the Pharmaceutical Industry
- Grade level commensurate with education and experience.
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
- Learns fast, grasps the "essence" and can change course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages to reality
Job Grades are determined by the country in which the payroll is based.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.