Manages oversight and governance of all Clinical Supply Chain external service providers (vendors) used to support project management for operations activities and other operations services with CMO providers including packaging, labeling, distribution, storage, returns, reconciliation, destruction, and comparator sourcing.
Responsible for identifying Clinical Supply Chain business needs (e.g. capability/capacity, specifications, standards) and working with procurement to further develop and/or improve appropriate external resourcing strategies (e.g. network strategy) to support the business need.
Establish best practices, set and maintain high performance standards across the vendor network, and establish mechanisms for early identification of poor Vendor/CMO performance, and work to address. Establish and monitor continuous improvement initiatives and performance measures with external network.
- Lead staff responsible for day to day operational oversight of outsourcing, vendor performance and delivery including but not limited to due diligence, RFIs/RFPs, supplier bid analysis, technical, financial, and quality due diligence, preparation of materials for team recommendation to appropriate governance bodies, contract award/decline, and supplier relationship management
- Manage Clinical Supply Operations staff including internal and external resources utilized to support operational activities including label development, primary and secondary packaging and labeling, distribution, storage, returns and reconciliation of all clinical trial materials. Ensures appropriate procedures and processes are in place and adhered to for effective oversight for all outsourced activities.
- Develop, implement and maintain risk assessment tools to evaluate vendor risk profiles and establish remediation strategies/plans to improve supply chain robustness.
- Chair Clinical Supply Chain sourcing committee/vendor selection committee and escalate exceptions or critical strategic vendor issues. Liaise closely with Procurement and Pharm Sci to represent Clinical Supply Chain perspectives and ensure transparency of strategy in the use of new vendors, alliances, and development partnerships.
- Monitors conformance of operations staff (internal and external) with Smart Supplies processes and Interactive Response Technology (IRT) standards.
- Works closelywith Planning, Business Process & Integration, and Logistics (Import/Export) leadership and staff in understanding project activities, goals, and timelines.
- Develops and implements programs to enhance Clinical Supplies group functioning and growth to attain best in class.
- Responsible for managing the budget for operations activities and oversees the timely generation of PO s, goods receipts, and monthly PO maintenance supporting Clinical Supply operation activities.
- Liaisewithother groups and departments, such as, Pharmaceutical Sciences, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality Assurance, external partners, and other key customers to assist in development and fulfillment ofclinical supply plans in support of the clinical study timelines and overall R&Dstrategy.
- Responsible for ensuring proper attendance at key meetings, communication and documenting of timelines and agreements, and communication of requirements to key cross functional partners including Clinical Operations, PharmSci, GMS, and QA.
SCOPE OF SUPERVISION:
- Exempt/Professional/Technical: 4-5
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor s degree in Life Sciences, Engineering, Pharmacy, Supply Chain/Logistics or related discipline. Advanced degree preferred.
Experience and Capabilities:
- 10+ years relevant Pharmaceutical Industry in Clinical Supply Chain management, CMC, Clinical Operations, contract supplier or related discipline, and managing relationships with vendors (i.e. CMOs/CROs).
- Proven experience and preferably leadership in vendor management, knowledge and experience of vendor selection methods, cGMP regulations, and management of suppliers of complex custom materials, proven experience coordinating among stakeholders with both business and technical priorities
- Job related experience dealing with global Clinical Supply operations and supervision of staff.
- Proven ability to lead and develop people.
- Ability to collaborate with diverse internal and external groups toward development of globalized approaches to Clinical Supplies project fulfillment.
- Knowledge of technology and/or software available to the industry that may streamline processes or improve efficiency for CTM manufacture, packaging, and/or distribution.
- Excellent working knowledge of GXP s and controlled substance regulations, 21 CFR, Annex 13 and EU CT Directive.
- Ability to influence stakeholders from many technical disciplines and at many levels
- Ability to lead and influence in a matrix organization
- Leadership skills and strategic problem solving ability; ability to predict issues and identify solutions
- Excellent communication and organizational skills are required.
- Fundamental knowledge of the global drug development process.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Flexibility to attend early meeting or late meetings due to timezone differences
- Requires approximately 5-10 % travel, which may include overnight and international travel to attend meetings, other Takeda sites, external manufactures, and another related travel.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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