Associate Director, GCSC Operations Lead

Takeda•Lexington, MA

4d•$154,400 - $242,550•Hybrid

About The Position

The Associate Director, GCSC Operations Lead is responsible for providing leadership and direction to facilitate the planning and execution of GCSC activities globally. Under the direction of the GCSC Director, the Associate Director manages Clinical Supply project delivery in support of Takeda Global R&D Clinical Trials and other supportive research or development needs; coordinates, procures and manages drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of clinical trial material. Works with both internal and external customers and suppliers to develop and communicate clinical supply project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner. The Associate Director, GCSC Operations Lead may also have personnel management and compensation planning responsibility and contributes actively to cross functional teams as required. Provides expertise, collaborates internally, and leads Global Clinical Supply Chain group initiatives including the active participation of the study oversight process for Global Clinical Supply Chain activities.

Requirements

Degree in Pharmacy, other scientific/technical degree, or significant job-related experience.
Minimum of 8 years relevant Pharmaceutical Industry and/or Contract/Service Provider experience is preferred.
Strong understanding of cGMP requirements
Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus

Nice To Haves

Experience with Medical Devices a plus.

Responsibilities

Works with GCSC Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines, and budgets.
Utilizes the Smart Supplies Database (PMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.
Understands IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of clinical trial material for shipment to sites.
Interfaces with Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported with in progress stability programs, and/or appropriate expiry dating.
Works closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
Works with GCSC Specialists to manage and troubleshoot shipment requests, drug returns, SmartSupplies, and IRT processes.
Works with them to ensure creation and maintenance of project documentation and according to established procedures and to manage clinical trial material inventory for projects assigned.
Oversees and coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers according to approved budget.
Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements.
Processes compliant invoices promptly to ensure optimal value to Takeda.
Key interface with Clinical Operations and Regulatory Affairs on all information required for Health Authority Submissions.
Evaluate and propose system improvements and technology enhancements/opportunities.
Manages and oversees external consultants and third-party vendors, including vendor selection and agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
Ensures that key project milestones are met across multiple programs; negotiates and communicates supply plan timelines to internal and external customers, partners and GCSC leadership team.
Accountable and responsible for amending budgets through defined change management processes.
Manages all finance activities with clinical team including request for proposal for bidding and vendor selection, purchase orders, and invoice approval.
Responsible for forecasting for materials, costs and managing variances across multiple programs with multiple late phase protocols.
Coaches and mentors less experienced staff.
Evaluate current processes, identify, and implement improvement opportunities and implement business processes related to the Clinical Supplies Team as required.
Manages specialized or high-profile projects
Serves as a back up to the director when needed
Effectively leads workstream to support departmental initiatives and goals