What are the responsibilities and job description for the Program Manager, Clinical Supply Chain Management position at BioSpace?
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Program Manager, Clinical Supply Chain Management’s 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
Qualifications:
Bachelor’s 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
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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Program Manager, Clinical Supply Chain Management’s 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
Qualifications:
Bachelor’s 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
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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html