Senior Manager, Clinical Supply Operations
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.
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
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%
Bachelor’s degree in Science or related field is required
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Annual Salary :Minimum $139,184.00 - Maximum $198,990.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
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.
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