Sunovion Senior Manager, Clinical Trial Material Management in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for a Senior Manager, Clinical Trial Material Management to join our Chemistry Pharmaceutical Science (CPS) team in Marlborough, MA.
The Senior Manager, Clinical Trial Material Management is responsible for executing organizational strategies and standards in one or multiple CTMM competencies, conducting and leading activities and operations of CTM supply to study subjects in complex clinical studies worldwide. CTMM competencies include Forecasting, Planning, Packaging, Labeling, Global Distribution, IRT Technology, Clinical Inventory Management System, Outsourcing Management, Capacity and Performance Metrics, 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.
Minimum Education, Experience, Knowledge and Skills:
B.S. / M.S / PhD in Science or Engineering with 10+ years post graduate experience including 7+ years in pharmaceutical industry and years managerial responsibility.
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 in clinical Interactive Response Technology and inventory databases.
Ability to comprehend and respond to complex problems and with effective problem-solving.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Lead the way to a healthier world by putting patients at the center of everything we do
We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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