Director, Clinical Supply Management – Nektar – San Francisco, CA, USA
Directs all aspects of pharmaceutical drug supply and distribution. This includes strategic and operational leadership relative to the direction, planning, and execution of commercial and clinical trial material supply and distribution. This individual will be responsible for the labeling, packaging, storage, distribution, disposal, and final reconciliation of products across the Nektar development pipeline. This includes oral and parenteral dosage forms. Plans and implements activities related to the clinical material planning, material control, inventory control, and shipping/receiving and stores functions. Directs material schedules, plans and coordinates the efficient movement of materials. Develop and execute operational strategies for designated programs. Collaborates cross-functionally to ensure corporate goals and objectives are met. This job contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Develop, implement, and maintain IVRS. Develops and maintains forecasts for clinical trial materials. Collaborates with Clinical Operations, Supply Management, Program Management, Regulatory Affairs, and Quality Assurance in the evaluation and selection of Nektar’s clinical packagers and distributors worldwide. Manage Nektar’s CROs for clinical packager/depot. Defines and obtains approval for the labeling and packaging requirements for Nektar products for clinical development in the United States and other countries. Prepares, plans and obtains internal approvals to implement the labeling and packaging requirements in a cost efficient and timely manner to ensure supply of released, packaged products for clinical use. Work with Regulatory to define label contents and text (ie English, translated languages) for US and ROW clinical development. Ensures budgets, schedules and performance requirements are met. Works closely with Accounting to review and approve invoices, and works closely with Supply Management and with suppliers when invoices are disputed. Ensures timely review and disposition of suppliers’ invoices. Manages Purchase Orders and monitors supplier’s performance against each contract, including cost tracking for each PO/contract. Ensures each clinical packaging and distribution project is managed within budget. Coordinate the day-to-day fulfillment of drug shipment requests for all products under clinical development in Nektar in a cost effective manner and in compliance with cGMP requirements. In collaboration with other Nektar colleagues, understand the product stability data and define acceptable practices and procedures for handling any excursions or deviations from recommended storage and handling conditions. Is the point person to receive the reports of any excursions or deviations which may occur during shipment, handling, and storage of product. Resolves such excursions or deviations in collaboration with Quality and defines and implements corrective/preventive actions to minimize the occurrence of such excursions or deviations. Establish and maintain a tracking system to document the genealogy and detailed usage history of all drug lots and for each clinical trial. Develop forecast model for clinical studies support, and facilitate development of long term plan, including budget and supplies forecast. May hire, mentor and develop staff.
A minimum of a Bachelors degree in a scientific discipline is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum of 13 years’ experience in the pharmaceutical or other related regulated industry is required. A thorough understanding of the FDA and cGMPs is required. A minimum of 10 years previous management experience is required. Must have a thorough knowledge of areas impacting Clinical Supply Management and the Supply Chain such as, Finance, Quality, Engineering, Manufacturing, and Facilities.
Experience and familiarity with cGMP practices and knowledge of CFR, ICH, CDER guidelines for storage, handling, and distribution of drug products, experience with IVRS systems is required. Experience in refrigeration materials (cold chain management) and controlled drug substances is preferred. Knowledgeable in global import/export requirements. Experience in successful management of relationships with contract service providers is required. Must be able to adhere to strict (or changing priority) project timelines and work independently with minimal supervision. The candidate must exhibit leadership skills with experience contributing to multi-disciplinary project teams. The candidate should have good communication skills (oral and written), strong initiative, be highly motivated and ability to work in a fast-paced, dynamic environment.