Associate Director, Clinical Supply Operations

Associate Director, Clinical Supply Operations is responsible for management of Clinical Supply Operations including investigational material activities for Phase I-IV assigned complex global studies, including coordination of packaging, labeling, and global distribution. 

Key Job Responsibilities

• Responsible for management of Clinical Supply Operations (CSO) group.
• Responsible for managing the strategic and technical aspects of clinical packaging and global supply chain support at contract packaging vendors. 
• Responsible for technical assessments and selection of contract packaging vendors to provide service for specific projects.
• Reviews and approves contracts for packaging and labeling activities conducted by clinical supply vendors.
• Partnering with contract packaging and IRT/IVRS vendors and internal functional groups to establish and maintain robust business and technical relationships.
• Review and approval of packaging and blinding plans for all clinical studies supported by CSO.
• Oversee department-initiated contract manufacturing, packaging, labeling, and distribution operations for clinical studies to meet business and strategic goals; ensure compliance with cGMPs, coordinating with Regulatory and Quality functions as required.
•  Assist with the preparation and maintenance of IMP forecasts for bulk and finished drug product.
• Assist with the establishment and improvement of Standard Operating Procedures (SOPs) and guidelines related to clinical supply management and operations.
• Assist with the business operational process improvements for the CSO group to increase efficiency to accelerate clinical development.
• Assist with continuous improvement initiatives, identify opportunities to optimize processes, and implement best practices to enhance efficiency and quality. 
• Lead and mentor a team of clinical supply professionals, fostering a culture of excellence, collaboration, and professional growth. 
• Responsible for budgetary activities and expenditures for CSO.
• Ability to travel up to 20%

Qualifications/ Required

Knowledge/ Experience and Skills:

- 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

- Understanding of the clinical development and clinical supplies process.

- Ability to supervise individuals and teams, including planning, delegation, communication, and time management.

- Ability to assist in managing the overall operational and budgetary activities of Clinical Supply Operations.

- Ability to maintain accurate records and files in accordance with GMPs, SOPs, and other regulatory requirements - Excellent Interpersonal and communication skills - Strong problem solving, planning, and organizational skills

- Ability to set and communicate goals and job standards.

- Ability to work in a flexible manner

- Strong detail-oriented, decision-making, negotiation, and multi-tasking skills

- Ability to work effectively in a multifunctional team environment.

- Ability to listen and coach

- Experience with e-mail, Windows, word-processing, database, spreadsheet applications) as well as Microsoft Project and PowerPoint 

Preferred: 

- Experience managing contract vendors.

Educational Qualifications

B.S. Degree in Life Sciences, Pharmacy or related scientific discipline + 9 years pharmaceutical industry experience

Competencies
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.

Minimum $160,530.00 - Maximum $240,005.00, plus incentive opportunity: 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.

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