Seagen

Associate Director Clinical Supply Management

Description

Summary

Leadership position responsible for the management of global clinical supply for Seagen clinical programs. Candidate will lead a team of clinical packaging managers to achieve Seagen clinical program goals. Expected to have extensive knowledge across many functional areas and resources related to global clinical packaging operations. Includes evaluation, selection and oversight of Packaging and Labeling CPO(s) and electronic data capture (EDC) systems, scheduling (international & domestic production/packaging), companion and comparator drug sourcing, analysis and reporting of production performance, analysis of clinical trial supply/demand trends, and creation and implementation of clinical product packaging.

Principal Responsibilities:

• Manages clinical packaging operation team, including staff coaching and guidance. Grows team as directed by budgeting efforts
• Develops and executes annual budget as guided by corporate plans
• Provides periodic study status reports on clinical drug product inventories, and planned production to Sr. Management, CMC and Clinical Operations Teams
• Develops and communicates accurate lead time requirements to the packaging and labeling and distribution CMOs, as well as the internal Seagen teams as required
• Acts as point of contact for third party CMOs and Comparator Sourcing suppliers
• Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish the program’s goals
• Leads the clinical supply module set up, supports implementation and maintains the inventory management functionality of the EDC systems
• Liaison between the CMC and the Clinical Operations teams and attends team meetings as required
• Supports Seagen’s systems implementation, reports and SOP creation as required
• Knows how to review and interpret clinical study protocol design, and can determine study labeling requirements. Develops master project plans to support the study
• Works closely with internal and external resources to optimize clinical supply availability and inventory investment
• Works closely with the Clinical Inventory and Production Planner to: Collect and analyze inventory information from vendors for the planning of clinical drug product, forecast study drug/companion/comparator requirements, assist the Clinical Production Planner with the lot information and tracking of inventory by study and country, and monitor the inventories of clinical product, including comparator drug at the distribution points
• Initiates clinical Finished Drug Product carton and label design, including blinded kit packaging and randomization schemes
• Recommends changes to labeling/packaging schedules based on study progress and or any changes with the study plans

Qualifications:

• A minimum of 10+ years working in a global biopharmaceutical Supply Chain or related industry
• Have an in-depth functional knowledge of Clinical Supply Operations
• Experience in Phase I to Phase IV global clinical study rollouts in a Clinical Supply leading role
• Demonstrated knowledge of global clinical labeling regulations/requirements and best practices
• Minimum of 7 years packaging operations/clinical supply experience within a pharmaceutical environment
• Experience and knowledge of cGMPs in a FDA regulated environment
• Experience working within an integrated enterprise level planning system (Oracle)
• Ability to travel 10%

Preferred Qualifications:

• BS/BA Degree in a business or supply chain field

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/26/2021