Sr. Director, Clinical Supply Management

Position Overview

Nektar has an exciting opportunity for a Sr. Director, Clinical Supply Management to join their Product Development Team.

Directs all aspects of pharmaceutical drug supply and distribution, including strategic and operational leadership relative to the direction, planning, and execution of commercial and clinical trial material supply and distribution. Responsible for the providing strategic oversight for 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 planning, material control, inventory control, and shipping/receiving and stores functions. Directs material schedules, generates and manages budgets, plans and coordinates the efficient movement of materials through development and execution of operational strategies. Collaborates cross-functionally to ensure corporate and function 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.

Responsibilities:

• Works on very complex issues where thorough analysis of situations or data requires an in-depth knowledge of the company.
• Through assessment of critical variables, identifies and evaluates fundamental issues providing strategy and direction for major functional areas.
• Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
• Ensures budgets and schedules meet corporate requirements.
• Develops and maintains forecasts for clinical trial materials across all programs.
• 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.
• Develop strategy for clinical supply and inventory management function of IVRS/IRT.
• 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.
• Hire, mentor, and develop staff.

Minimum Qualification Requirements:

• 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 15 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 12 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 must 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.