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Job Summary

The Senior Manager, Clinical Trail Materials is investigational material activities for Phase I-IV assigned complex global studies, including coordination of packaging, labeling, distribution contractors and global distribution. Also ensures on time startup of new studies by having supplies available as required. In addition, responsible for providing oversight to other staff as needed.

Job Description

• Focuses on the delivery and quality of the contracted clinical services within a project to achieve customer satisfaction

• Focus is on leveraging clinical supplies expertise along with the diverse solutions to drive operational excellence particularly in respect to the clinical project support and on-time high quality data collection

• Provides leadership of the clinical supplies team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs, policies and practices

• Review protocols and designs appropriate supply chain strategy

• Create and revise Standard Operating Procedures as required

• Oversight of specifications for automated randomization and drug supply management systems

• Oversee a variety of logistics issues, including but are not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing

• Identify key stakeholders within CMC and clinical project teams to ensure on time availability of drug supplies

• Lead process improvement efforts and may develop specific department plans and procedures

• Accountable for the clinical supply delivery per contract, ensuring consistent use of tools and compliance with standard processes, policies and procedures

• Partner with the project leaders to confirm objectives of the clinical supply team according to agreed-upon contract, strategy and approach. Effectively communicate and assess performance against these agreed objectives

• Monitor clinical supplies progress against contract and prepare/present project information proactively to all stakeholders internally and externally as required

• Manage risks (positive and negative) which could impact on the clinical supply delivery of the project and determine contingencies. Partner with functional leaders in problem solving and resolution efforts

• Achieve project quality by identifying quality risks and issues, responding to issues which impact the clinical supplies delivery, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans

• Support the project leader in ensuring the financial success of the project

• Identify changes in scope and support project leader in completion of the change control process

• Adopt corporate initiatives and changes and serve as a change advocate when necessary

• Provide input to line managers of their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development

Qualifications/ Required

Knowledge/ Experience and Skills:

• At least 12+ years of experience in packaging, labeling, distribution and logistics of CTM and/or commercial products, managing clinical supply, and related activities

• Experience in overseeing external manufacturing and CMO relationships

• Thorough knowledge of GMPs (current Good Manufacturing Practices for Finished Pharmaceuticals: CFR title 21, parts 210 and 211), GCPs (current Good Clinical Practices) and EU regulations regarding clinical studies

• Ability to work strategically and independently with internal and external groups on multiple projects

• Excellent written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external manufacturing partners

• Proficient with all MS Office application skills

• Excellent interpersonal and communication skills

• Ability to operate in a multi-cultural, multifaceted corporate environment

• Be task & detail oriented

• Travel approximately 10%

Educational Qualifications

• Bachelor’s degree in Science or related field is required

#LI-Hybrid

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.