Job Description

The Associate Director, Comparator Management is responsible for the sourcing and product management (assessment, order, delivery, release and applicable product blinding) of Non-Company commercial (comparator) products for all clinical trials. The incumbent will collaborate closely with internal customers including the Clinical Supply Project Managers (CSPM) and function as an independent expert in supply planning, product management and buyer of non-Company commercial products. Candidates should have proven strong expertise in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), commercial medicinal products and buying from external drug wholesalers specialized in comparator sourcing.

Primary activities include, but are not limited to:

• Sourcing and product management for comparator products.

• Sourcing and procuring comparator samples and documentation for comparator label and packaging component evaluation.

• Creating and maintaining Material Masters and provide SAP Process Orders for de-packaging, pre-packaging, manipulation, and placebo manufacturing & packaging according to the routing.

• Managing comparator blinding including but not limited to de-printing and over-encapsulation.

• Effective communication with internal and external stakeholders.

• Forecasting comparator pricing information to enable accurate consolidated budget planning, expense forecasting and management.

• Maintaining oversight of shipping activities, monitoring target delivery dates and supporting release activities.

• Creating and maintaining Purchase Requests as well as requesting Purchase Orders in SAP.

• Utilizing systems to document/execute GxP activities.

• Promoting continual creative improvement and actively contribute to a culture of innovation, excellence and accountability.

• Providing mentoring and coaching to team members.

• Champion and drive identified business process improvement initiatives, as needed.

Education:

• Bachelor's degree in the supply chain, scientific or business discipline.

Required Experience & Skills:

• Minimum 5 years experience in clinical supplies or procurement with knowledge of comparator sourcing markets and processes

• Knowledge of current Good Manufacturing and Distribution Practices (cGMP/GDP) and Standard Operating Procedure execution

• Excellent verbal and written communication skills, and effective interactive skills to partner with various stakeholders

• Ability to work effectively across boundaries to build strong collaborative relations with other internal and external partners.

• Competence in process optimization, including design and execution.

• Strong project management skills and ability to organize and manage multiple tasks at one time and meet deadlines

• High proficiency in Microsoft applications (Word, Excel, PowerPoint, Teams)

• Experience with SAP

Preferred Skills:

• Project management certification (e.g. PMP, CAPM)

• Knowledge of Operational Excellence methodology such as Six Sigma and Lean methods principles and tools.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

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Requisition ID:R325129