Associate Director, Clinical Trial Material Management - Marlborough, MA | Biospace
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Associate Director, Clinical Trial Material Management

Sunovion Pharmaceuticals Inc.

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Location:
Marlborough, MA
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
5903BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Trial,

Job Description

The Associate Director, Clinical Trial Material (CTM) Management, is responsible for executing and refining organizational strategies and standards in one or multiple CTM Management competencies, conducting and leading activities and operations of CTM supply to study subjects in complex clinical studies worldwide. CTM Management competencies include Forecasting and Planning, Packaging and Labeling, Global Distribution, IRT Technology, Clinical Inventory Management System, Outsourcing Management, Capacity and Performance Metric, Project Management, and Conformance of Quality and Compliance requirements.
- Develop and implement harmonized best practice policy and operational procedures that in-line with the integration of Sunovion R&D organization and in–line with CTM supply needs of Sunovion managed clinical studies.

- Determine and build new or advanced expertise to match up with CTM supply needs driven by the clinical program dynamics, new therapeutically area(s) and product development prioritization.

- Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast. Conduct capacity planning to create a supply plan for all phases including complex phase III studies or dose flex adaptive studies. Identify the most suitable CRO/CMO and initiate contracts. Develop CTM project plan and integrate the plan with clinical trial timeline. Oversee work assignment and deliverables for CTM suppliers, and collaborate on and review of pre- and post-executed batch records to ensure timely completion of CTM milestones and internal development work.

- Manage distribution/logistics activities of complex supply chains by evaluating supply strategies, tracking inventories, tracking expiry dates, initiating bulk shipments, coordinating import/export requirements. Coordinate set up/planning/end-user testing/ of Interactive Response Technology (IRT, e.g. IVRS, IWR) in line with study needs. Ensure integrity of all clinical supply chain management databases used for managing clinical trial requirements.

- Manage operating budgets for sourced services and activities. Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure and cross-functional collaboration. Comply with ICH, Federal U.S. and any pertinent local regulations and adhere to Sunovion SOP and Guidance Documents.

Requirements

Education level and/or relevant experience(s):
B.S. / M.S. / Ph.D. in Science or Engineering with 12+ years post graduate experience including 8+ years in pharmaceutical industry and 4+ years with managerial responsibility preferred.

Knowledge and skills (general and technical):
- Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines.
- Working knowledge of supply and distribution operation.
- Working knowledge of establish and managing partnership with CMO and CRO.
- Working knowledge of Clinical Trial Materials development, manufacturing, packaging and labeling.
- Leadership skills that motivate and energize a group or an individual for peak performance.
- Excellent verbal and written communication skills and confidently communicate with all level of staff.
- Proficient Microsoft Office skills and knowledge of Interactive Response Technology and databases.
- Ability to comprehend and respond to complex problems and with effective problem-solving.