Vice President, Clinical Supply Chain

About the role

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 and launch 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.

Responsibilities

• Responsible for the Nektar manufacturing supply chain including critical intermediates, drug substance, drug product, and combination product, as well as labeling and packaging.
• Supports the current clinical supply organization and the transition for launch and commercialization, including 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.
• 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 enhancement of labeling and packaging requirements for clinical development in the United States and ROW.
• Supports 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.
• Supports supplier performance monitoring, including development and monitoring of KPIs, 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.

Qualifications

• Thorough understanding of global health authority regulations including FDA and EMA.
• Thorough knowledge of areas impacting Clinical and Commercial Supply Management and the elements of Supply Chain logistics, including Finance, Quality, Engineering, Manufacturing, and Facilities.
• Experience and familiarity with cGMP practices and knowledge of CFR, ICH, and CDER guidelines for storage, handling, and distribution of drug products.
• Experience with RTSM systems.
• Experience in cold chain management (preferred).
• Knowledge of global import/export requirements.
• Track record of successfully leading multidisciplinary teams through challenging milestones.
• Successful track record of hiring, training, and motivating teams to the highest level of performance.
• 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.
• Excellent planning, organizing, and management skills.
• 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.

Professional Experience

15 years of experience in the biotechnology, pharmaceutical or other related regulated industry. 12 years previous management experience.