Principal Project Manager, Clinical Supply

Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1 IV clinical trials highly complex study designs and management of studies with partner companies. Expected to work independently with very minimal oversight and supervision.

Responsibilities

• Forecasts plans schedules coordinate and executes 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 IRT vendors quality assurance 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.
• Must be SME in some aspect of clinical supply project management activities e.g. ADME EDP Customs expert who routinely expands and shares knowledge with global group.
• Successfully leads and participates in within function and cross functional process improvement initiatives.
• Leads in troubleshooting and resolving clinical supply related issues ensuring that project needs and priorities are understood by team members. Coaches and mentors staff members on clinical supply requirements and topics. Provides input and recommendation to DSMs on project timing and resource requirements.

Qualifications :

• Bachelors Degree in Life Science or Physical Science preferred (will consider Business Administration Math or Engineering with appropriate work experience) with at least 3- 5 years in the Pharmaceutical Industry
• Must have 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.
• 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.
• 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.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs. 

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time