Business Services & Consulting • all cities, ND 29
Leads and oversees the Nektar Supply Chain function, playing a key role within the Pharmaceutical Development & Manufacturing organization at the corporate level.Creates and articulates the vision and strategy for clinical supply operations andlaunch and commercialization across the Nektar development pipeline.Directs all aspects of pharmaceutical drug supply and distribution, including strategic and operational leadership for commercial and clinical trial material supply, labeling, packaging, storage, distribution, disposal, and final reconciliation of products.
This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities
Responsible for the Nektar manufacturing supply chain including critical intermediates, drug substance, drug product, and combination product. Additionally this role will support labeling, and packaging. The role will support the current clinical supply organization and support the transition of the organization for launch and commercialization including the assessment and development of launch and commercial forecasts.
Supports the Clinical Supply Management function in assessing internal resources and effective deployment of the team to achieve project and business objectives in a timely manner. Interacts internally and externally with executive level management, requiring negotiation of key matters and influencing policymaking.
Builds and develops infrastructure necessary to support all clinical supply activities, including capital requirements. Plans, develops and directs, the SNOP process to support and accomplish budgeted financial objectives and execute the company business plan on time and within budget.
Supports and ensures efficient clinical supply operations across all sites. Maintains and develops tools for oversight of clinical trial forecasting and commercial forecasting in partnership with the finance department.
Develops and maintains forecasts for clinical trial materials as well as commercial launch supplies across critical intermediates and final products
Directs the evaluation and selection of clinical packagers and distributors worldwide in collaboration with Clinical Operations, Clinical Supply Management, Program Management, Regulatory Affairs, and Quality.
Supports the oversight of CRO activities for clinical packager/depot operations including the enhancement of labeling and packaging requirements for clinical development in the United States and ROW. Support the internal approval process to implement labeling and packaging requirements in a cost-efficient and timely manner.
Directs budget development and ensures financial objectives are met. Support supplier performance monitoring, including the development and monitoring of KPIs. Supports contract management, and cost tracking.
Supports the day-to-day fulfillment of intermediate and final drug shipment requests in compliance with cGMP requirements.
Establishes and directs tracking systems to document genealogy and usage history of all drug lots. Directs forecast model development for clinical studies support and long-term planning, including budget and supplies forecast for launch and commercialization.
Represents the company as the Supply Chain expert before U.S. and international regulatory authorities. Hires, develops, trains, and evaluates staff to ensure efficient operation of the clinical supply function.
Additional Qualifications
Has thorough understanding of global health authority regulations including FDA and EMA.Possesses thorough knowledge of areas impacting Clinical and Commercial Supply Management and the elements of Supply Chain logistics, including Finance, Quality, Engineering, Manufacturing, and Facilities.Has experience and familiarity with cGMP practices and knowledge of CFR, ICH, and CDER guidelines for storage, handling, and distribution of drug products.Has experience with RTSM systems.Has experience in cold chain management (preferred).Knows global import/export requirements.Demonstrates a track record of successfully leading multidisciplinary teams through challenging milestones.
Demonstrates a successful track record of hiring, training, and motivating teams to the highest level of performance.Has experience evaluating, negotiating, and administering multiple successful relationships with partners and contract service providers, understanding how to set proper milestones to track progress and hold partners accountable.Leads by example and models collaborative behavior, willing to make key decisions and effective in getting the team behind decisions.Possesses excellent planning, organizing, and management skills.
Possesses exceptional interpersonal, negotiation, and communication skills (oral and written) with ability to interact with colleagues and partners at all levels, including executive management.Adheres to strict and changing priority project timelines and works independently.
Education or Degree Requirements
Bachelor's degree in a scientific discipline. Advanced degree preferred. Equivalent experience may be accepted.
Minimum Professional Experience
15 years of experience in the pharmaceutical or other related regulated industry. 12 years previous management experience.
Additional Information
Nektar currently anticipates the base salary for the Vice President, Clinical Supply Management to range from $330,000 to $375,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience.This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion.
The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
Leads and oversees the Nektar Supply Chain function, playing a key role within the Pharmaceutical Development & Manufacturing organization at the corporate level.Creates and articulates the vision and strategy for clinical supply operations andlaunch and commercialization across the Nektar development pipeline.Directs all aspects of pharmaceutical drug supply and distribution, including strategic and operational leadership for commercial and clinical trial material supply, labeling, packaging, storage, distribution, disposal, and final reconciliation of products.
This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Essential Duties and Responsibilities
Responsible for the Nektar manufacturing supply chain including critical intermediates, drug substance, drug product, and combination product. Additionally this role will support labeling, and packaging. The role will support the current clinical supply organization and support the transition of the organization for launch and commercialization including the assessment and development of launch and commercial forecasts.
Supports the Clinical Supply Management function in assessing internal resources and effective deployment of the team to achieve project and business objectives in a timely manner. Interacts internally and externally with executive level management, requiring negotiation of key matters and influencing policymaking.
Builds and develops infrastructure necessary to support all clinical supply activities, including capital requirements. Plans, develops and directs, the SNOP process to support and accomplish budgeted financial objectives and execute the company business plan on time and within budget.
Supports and ensures efficient clinical supply operations across all sites. Maintains and develops tools for oversight of clinical trial forecasting and commercial forecasting in partnership with the finance department.
Develops and maintains forecasts for clinical trial materials as well as commercial launch supplies across critical intermediates and final products
Directs the evaluation and selection of clinical packagers and distributors worldwide in collaboration with Clinical Operations, Clinical Supply Management, Program Management, Regulatory Affairs, and Quality.
Supports the oversight of CRO activities for clinical packager/depot operations including the enhancement of labeling and packaging requirements for clinical development in the United States and ROW. Support the internal approval process to implement labeling and packaging requirements in a cost-efficient and timely manner.
Directs budget development and ensures financial objectives are met. Support supplier performance monitoring, including the development and monitoring of KPIs. Supports contract management, and cost tracking.
Supports the day-to-day fulfillment of intermediate and final drug shipment requests in compliance with cGMP requirements.
Establishes and directs tracking systems to document genealogy and usage history of all drug lots. Directs forecast model development for clinical studies support and long-term planning, including budget and supplies forecast for launch and commercialization.
Represents the company as the Supply Chain expert before U.S. and international regulatory authorities. Hires, develops, trains, and evaluates staff to ensure efficient operation of the clinical supply function.
Additional Qualifications
Has thorough understanding of global health authority regulations including FDA and EMA.Possesses thorough knowledge of areas impacting Clinical and Commercial Supply Management and the elements of Supply Chain logistics, including Finance, Quality, Engineering, Manufacturing, and Facilities.Has experience and familiarity with cGMP practices and knowledge of CFR, ICH, and CDER guidelines for storage, handling, and distribution of drug products.Has experience with RTSM systems.Has experience in cold chain management (preferred).Knows global import/export requirements.Demonstrates a track record of successfully leading multidisciplinary teams through challenging milestones.
Demonstrates a successful track record of hiring, training, and motivating teams to the highest level of performance.Has experience evaluating, negotiating, and administering multiple successful relationships with partners and contract service providers, understanding how to set proper milestones to track progress and hold partners accountable.Leads by example and models collaborative behavior, willing to make key decisions and effective in getting the team behind decisions.Possesses excellent planning, organizing, and management skills.
Possesses exceptional interpersonal, negotiation, and communication skills (oral and written) with ability to interact with colleagues and partners at all levels, including executive management.Adheres to strict and changing priority project timelines and works independently.
Education or Degree Requirements
Bachelor's degree in a scientific discipline. Advanced degree preferred. Equivalent experience may be accepted.
Minimum Professional Experience
15 years of experience in the pharmaceutical or other related regulated industry. 12 years previous management experience.
Additional Information
Nektar currently anticipates the base salary for the Vice President, Clinical Supply Management to range from $330,000 to $375,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience.This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion.
The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
