AD, Clinical Supply Management – Nektar – San Francisco, CA, USA
Directs all aspects of pharmaceutical clinical drug supply logistics. Provides strategic and operational cross-functional leadership of clinical trial material supply planning and distribution. Actively manages the forecasting, planning, scheduling, coordination, and implementation of clinical supplies for multiple projects, which may involve controlled substances and global distribution. Responsibilities also include labeling, packaging, storage, distribution, disposal, and final reconciliation of products across the Nektar development pipeline of oral and parenteral dosage forms. Plans and implements activities related to the clinical material product and packaging requirements, material control, inventory control, and shipping/receiving and storage functions. This position directs material schedules, generates budgets, plans and coordinates the efficient movement of materials through the development and execution of operational strategies for the designated programs. Collaborates cross-functionally to ensure corporate goals and objectives are met.
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 to ensure the timely supply of clinical trial material to enrolled sites. Manage Nektar’s CROs for clinical packager/depot. Coordinates definition of drug product for packaging, assess product dating, storage conditions, primary components, analytical testing needs, and retain quantities.
Works in collaboration with the Clinical team to develop the clinical supplies section for protocols, to develop the clinical supplies plan and to create labels. Collaborates with clinical study team to develop, implement, and maintain IVRS. Works with Biostatistics to determine requirements for randomization and material codes and ensures the packaged drug products are consistent with the code assignments.
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. Works with Quality to ensure supplies are prepared in accordance with applicable GMP and GCP regulations, US and global requirements as well as DEA regulations.
Manage Nektar’s CROs for clinical packager/depot. 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 and GCP 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 products. Resolves such excursions or deviations in collaboration with Nektar 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.
Manages the destruction of drug product in accordance with GMP and DEA regulations. Works with Regulatory to provide clinical supplies information for INDs, NDAs or ARs and provides input to other documents as necessary.
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 10 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 8 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.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.