Big Pharmaceutical Organisation

Provides strategic direction for clinical supply chain planning activities for assigned programs in the R&D Portfolio. Develops the program level supply plan for new studies and monitors ongoing study level activity to ensure sufficient supply. Communicates with the Drug Planning Coordinator/Specialist in the development of the Drug Provision Plan to ensure proper allocation and distribution of supplies. Communicates to key stakeholders regarding adherence to project strategy and timelines.
Key Responsibilities and Major Duties
o    Works cross-functionally as part of a dynamic team across CSO to manage end-to-end clinical drug supply chain availability for assigned projects in the R&D Portfolio. Identifies strategic direction and optimal supply strategy aligned with R&D pipeline goals. 
o   Develops the program level demand planning forecasts and budgets based on the book of work for clinical drug supplies through all phases of clinical development for assigned programs. This includes providing to key stakeholders: study cost estimates, monthly budget projections, demand requirements and timing for drug substance and drug product for the manufacture, as well as packaging, labeling, and release for finished goods for delivery to the warehouse depots in time for study needs.
o    Reviews real-time, comprehensive study level demand projections for ongoing studies from the Drug Planning Coordinator/Specialist on a monthly basis. Incorporates new future study demand and uses this comprehensive view to exercise judgment to influence and prioritize manufacturing and purchasing decisions. Adjusts the Program supply plan for new study demand requirements. Participates in proactive discussions and decisions regarding adjustments to the Program supply plan as needed during Long Range Operations Planning (LROP) Team meetings. Adjusts budget as required in response to changing study needs. 
o    Actively participates in clinical study team and various development and operations meetings by providing feedback across functional areas when required from a clinical supply perspective. Identifies potential risks and escalates to the appropriate stakeholders as needed.
o    Plans for excipients/ancillary supply for studies involving on-site compounding. Interfaces with Integrated Supply Chain to ensure the availability of appropriate quantities and dating for excipients as needed. 
o    Works with the labeling group to prepare initial packaging and labeling options and communicates these options to the clinical leader for negotiation and finalization for optimal study dosing.
o    Acts as the primary Drug Supply liaison for collaborations with Contact Research and Manufacturing organizations (CRO’s and CMOs), drug sourcing vendors and other strategic alliance partners. Reviews and provides feedback to drug supply sections of collaboration agreements, and liaises with Legal to develop and finalize Clinical Supply Agreements when required. 
o    Performs various tasks related to study implementation which includes but is not limited to: providing input to the clinical protocol, the final Clinical Study Report, generation of justification memos, purchase requisitions, independent requirement orders, and packaging specifications for planning and release of drug supply and comparators in time to meet the study timelines.
o    Attends Global Clinical Trial Unit Submission Tracking Meetings. Where required, provides input for regulatory documentation and provides feedback to address responses to Health Authority requests. Submits Tracking and Notification for drug related changes to manufacturing, packaging and labeling as required. 

Validates and approves Product Information Listings as required for study database locks and regulatory filings. Works with Drug Planning Coordinator/Specialist to provide batch extract files as requested.
Acts as interface to key customers for information and training as it pertains to drug formulation and dosing questions, overall demand planning, IRT set-up, and Investigator Training for Drug Supply and IRT.
Initiates and closes field complaints or Quality Events in TrackWise when required by providing supporting information and CAPA’s as needed while ensuring resolution within company timelines.
o    Provides leadership on key task forces for improvement initiatives and procedural updates. Recommends and implements ways to improve the efficiency of clinical supply processes by identifying emerging trends and technologies, and applying best practices.

Supervisory Responsibility
No Direct Reports. Drug Planning Coordinator/Specialist position indirectly report to DSM as part of matrix team. 

Collaborates with the Label Group when new drug labels are needed, as well as with manufacturing, procurement, packaging and labeling team to ensure clinical supply is available as needed based on study timelines. Also collaborates with Integrated Development Team (IDT) Drug Planning Coordinator/Specialist, IRT Project Team, Logistics Team (Shipment Execution Coordinator and Shipment Execution Team Lead) and the Clinical Protocol Team (including Contract Research Organizations, Global Data Strategies and Solutions/Medical Data Operations) in order to accurately plan drug supply to support clinical studies, investigator sponsored research, and early patient access programs within the required timelines. Supports Data Management, Global Regulatory Safety and Biometrics (GRS) by preparing product information listings and batch extract listings for database locks and filings.

Interested candidates may contact at "Praveen.arora (@) artechinfo.com or 973-507-7593