Manager, Clinical Supply Operations

Job Summary

Manager, Clinical Supply Operations manages Phase I-IV clinical studies, including coordination of packaging, labeling, blinding of investigational materials and global distribution.

Job Description

• Reviews and approves contracts for packaging and labeling activities conducted by clinical supply vendors.
• Assist with forecasting and ordering bulk research drugs from manufacturing department.
• Support with developing study specific clinical supply plans and contribute to Pharmacy Manuals and supply related training/instructional materials.
• Support with the development of clinical supply packaging configurations based on clinical protocols
• Serve as primary point of contact for contract packaging, distribution, and storage vendors
• Prepare clinical packaging timelines and coordinates activities of packaging contractors, including packaging and labeling, global supply chain, and site returns and destruction.
• Monitor and maintain budget for assigned projects.
• Support with design clinical labels to meet protocol, FDA, EU and country specific requirements.
• Write or review the Study Medication Sections of the Clinical Protocols, Clinical Study Reports, IND and other regulatory submissions.
• Maintain investigational Materials inventories.
• Train investigators and CROs on protocol procedures related to investigational materials.
• Participate in clinical development team meetings for assigned projects.
• Coordinate investigational material destruction as required.
• Coordinate the release of clinical supplies with other functional groups (i.e. Quality Assurance and Quality Control).
• Coordinate QP release of investigational materials to be used in the EU.
• Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations
• Work with cross-functional team to develop study-specific IRT/IVRS specifications and requirements providing clinical supplies management perspective.

Qualifications

• B.S. Degree in Life Sciences, Pharmacy or related scientific discipline + 3 years pharmaceutical industry experience
• Some 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
• Some understanding of the clinical development and clinical supplies process
• 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
• Travel approximately 10%

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 $117,027.00 - Maximum $167,420.00, 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, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insuranc