Purpose
The Program Manager Clinical Supply Chain Managements primary responsibility is to manage the clinical supply chain for early phase (uncomplicated) compounds. The completion of clinical trials is the rate-limiting step for filing of new drug applications and ultimately to product commercialization. The on-time initiation uninterrupted conduct and completion of clinical studies is dependent on the timely delivery of clinical supplies of top quality to the clinical sites.
Responsibilities
- Define and implement a global clinical supply strategy in conjunction with mentor or experienced Drug Supply Manager
- Ensure all clinical supplies (early phase affiliate studies and IIS) are delivered on time on budget and of top quality with no studies interrupted or delayed due to clinical supplies
- Define and manage external budget for compounds (comparators co-meds over-encapsulation depots and importation costs)
- Represent the clinical supply chain on Integrated Evidence Strategy Teams (IESTs)
- Participate and contribute to Product Presentation and Device Strategy Team (PPDST) meetings
- Define API and drug product requirements and delivery dates to support the clinical supply chain
- Matrix management of Clinical Supply Project Managers (CSPMs) supporting the global clinical supply chain
- Allocate bulk drug product to CSPMs minimizing wastage
- Lead the recovery of clinical supplies during a product recall support the evaluation and approval of non-medical complaints (NMCs) exception reports and recalls
Qualifications :
- Bachelors Degree or higher in Pharmacy or Science
- 5-7 years experience in the pharmaceutical industry
- Demonstrated understanding of the overall drug development process
- Experience in project management planning forecasting budgeting
- Excellent interpersonal team and leadership skills
- Sound knowledge of GxP
Key Stakeholders: Development Sciences leadership Clinical Development leadership
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 short-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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
PurposeThe Program Manager Clinical Supply Chain Managements primary responsibility is to manage the clinical supply chain for early phase (uncomplicated) compounds. The completion of clinical trials is the rate-limiting step for filing of new drug applications and ultimately to product commercializ...
Purpose
The Program Manager Clinical Supply Chain Managements primary responsibility is to manage the clinical supply chain for early phase (uncomplicated) compounds. The completion of clinical trials is the rate-limiting step for filing of new drug applications and ultimately to product commercialization. The on-time initiation uninterrupted conduct and completion of clinical studies is dependent on the timely delivery of clinical supplies of top quality to the clinical sites.
Responsibilities
- Define and implement a global clinical supply strategy in conjunction with mentor or experienced Drug Supply Manager
- Ensure all clinical supplies (early phase affiliate studies and IIS) are delivered on time on budget and of top quality with no studies interrupted or delayed due to clinical supplies
- Define and manage external budget for compounds (comparators co-meds over-encapsulation depots and importation costs)
- Represent the clinical supply chain on Integrated Evidence Strategy Teams (IESTs)
- Participate and contribute to Product Presentation and Device Strategy Team (PPDST) meetings
- Define API and drug product requirements and delivery dates to support the clinical supply chain
- Matrix management of Clinical Supply Project Managers (CSPMs) supporting the global clinical supply chain
- Allocate bulk drug product to CSPMs minimizing wastage
- Lead the recovery of clinical supplies during a product recall support the evaluation and approval of non-medical complaints (NMCs) exception reports and recalls
Qualifications :
- Bachelors Degree or higher in Pharmacy or Science
- 5-7 years experience in the pharmaceutical industry
- Demonstrated understanding of the overall drug development process
- Experience in project management planning forecasting budgeting
- Excellent interpersonal team and leadership skills
- Sound knowledge of GxP
Key Stakeholders: Development Sciences leadership Clinical Development leadership
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 short-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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
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