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Director, Clinical Supplies

New York, NY 10001

Posted: 06/06/2024 Employment Type: Direct Hire/Perm Job Category: Other Job Number: 605407 Is job remote?: Yes Country: United States

Job Description

Position Summary:      
  • Responsible for the oversight and management of Clinical Supply Chain Operations for client, in accordance with current GMPs and local regulatory requirements.
  • Manages Clinical Supply Chain personnel to ensure on-time delivery of Finished Goods and to maintain and implement efficient and cost-effective Supply Chain strategies.
  • Assesses Supply Chain risks and develops/implements risk mitigation plans, accordingly.
  • Directs annual Clinical Supply Chain budget forecast and spend.
  • Liaison with client CMC, and third party vendors to facilitate Supply Chain operations.
  • Operates as a key contributor with  internal business partners in QA, RA, MA, ClinOps, & Commercial to maintain an organizational culture of continuous quality improvement.
  • Responsible for oversight and management of IRT service providers, to support Clinical Development activities.
Responsibilities and Duties:
  • Directs operations for the Clinical Supplies department and oversees designated Clinical Supply personnel at client
  • Assigns programs to Clinical Supplies personnel, to ensure sufficient Supply Chain coverage for all client development compounds from Phase I through Phase 4, including IIT, EAP and SAP format programs.
  • Ensures that Clinical Supplies department adheres to GMP processes, as it relates to the life cycle of Clinical and Commercial Supplies preparation, release, distribution and destruction.
  • Supports the development and growth of Clinical Supplies department personnel, to ensure that team members have sufficient training and experience to independently manage their assigned programs.
  • Supports Commercial Supply Chain through the transition from Clinical Supplies to Commercial Supply. 
  • Develops and oversees implementation of procedures, tools and systems to support the Clinical Supply Chain planning and execution and to align with GMPs and regulatory requirements.
  • Serves as the Clinical Supplies representative on cross functional study teams and program teams, develops and plans global Supply Chain strategy and proactively identifies Supply Chain issues to pharmaceutical development and post marketing projects.
  • Assesses the impact of new regulations, guidance or enforcements and advises Clinical Supplies personnel on changes to supply chain strategies, with emphasis on research and development activities.
  • Provide team with guidance on international regulatory considerations associated with import and export of clinical products.
  • Adopt supply strategies from bulk to finished product in view of changes in regulatory environment and drug supply environment, (regional and global drug shortages).
  • Directs annual Clinical Supply Chain budget forecast and spend.
  • Maintains oversight of all contracted Clinical Supplies packagers, distributors, suppliers and testing sites to ensure compliance with GMPs and ensure business needs are being sufficiently met.
  • Act as SME for Demand Planning System and oversee governance for maintenance and system improvements.
Educational Requirements:   
  • Bachelor's degree in life sciences, logistics, pharmacy or equivalent.
  • Previous experience with pharmaceutical supply chain, clinical trials and product R&D.
  • Knowledge of CMC requirements, as it pertains to product development.
Experience: 
  • Knowledge of current Good Manufacturing Practices (cGMP) with some manufacturing experience with oral products preferred.
  • Minimum 10 years of experience in the pharmaceutical industry with at least 7 years of clinical or commercial supply chain experience.
  • Previous experience managing Clinical or Commercial Supply Chain functional areas and external packaging and distribution CROs and Clinical Supply Chain consultants.
  • Demonstrates a thorough understanding of the clinical trial process: clinical supply packaging/labeling/distribution, Supply and Demand forecasting, Vendor Management, Scheduling, IXRS development, clinical trial operations, project management, research and development, Budget setting.
  • Experience with writing and implementing Supply Chain Procedures and systems.
  • Experience with the manufacturing and packaging of Oncology products preferred.
  • In depth knowledge of QP release process and other international regulations.
  • General knowledge of GXP principles.
  • Hands-on experience working with global trials involving, IXRS, etc.
  • This position may require some travel.
Other Skills and Abilities:
  • Ability to delegate effectively.
  • Detailed and quality oriented.
  • Excellent written and oral communications.
  • Ability to analyze and interpret technical information.
  • Solution oriented with exceptional collaboration skills.
  • A team player and able to work in a dynamic environment with attention to high quality results.
  • Ability to interact and communicate with partners for both planning and operational execution of day to day activities.
  • Ability to multi-task and prioritize efforts effectively.

**CO/NY candidates may not be considered 
 
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