Principal Clinical Supply Project Manager

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

Basic:

Education/ Experience

• Bachelor’s Degree required, preferably in physical science, math, engineering, or pharmacy
• 8+ years total experience in the Pharmaceutical Industry 
• Experience in one of the following areas: Drug Discovery (e.g. Process Chemistry, Analytical Chemistry), Drug Development (e.g. formulation), Clinical Operations (e.g. Clinical Project Management), Supply Chain (e.g. Clinical Supplies Project Management), Quality Assurance.
• High degree of flexibility and a strong aptitude for identifying innovative approaches in decision-making and problem solving. Must be able to proactively and effectively recognize, quantify and mitigate potential risks. Proven leadership skills in the management of complex projects.
• Ability to think in multiple dimensions and balance many priorities to ensure that supplies are delivered within optimal timing, on budget and are of the highest quality while ensuring adherence to applicable regulatory requirements.
• Effective communication skills.
• Extensive knowledge of the clinical supply industry and global clinical trial requirements.
• Grade level commensurate with education and experience.

 

Applicable to California Applicants Only 

The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future. 

The salary range for this role is posted below 

This job is eligible to participate in our short-term incentive program 

This job is eligible to participate in our long-term incentive programs 

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.