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Job Description
OBJECTIVES/PURPOSE:
- Under the direction of the GCSC Team Lead, the Clinical Supplies Senior Operations Lead is responsible for Clinical Supply delivery in support of Takeda R&D Global Clinical Trials and other supportive research or development needs, and works with both internal and external customers and suppliers in order to develop and communicate project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner.
- The GCSC Senior Manager Operations Lead’s areas of responsibility include coordination and management of the procurement, packaging, labeling, distribution return, reconciliation, and destruction activities of clinical trial materials.
- Leads GCSC group initiatives including the active participation of the study oversight process for GCSC activities for Takeda’s clinical trial operating model.
- Responsible for identifying, recommending, and implementing strategies that optimize the use of CTM and execute the project as cost effective, efficiently, and successfully as possible. Partners with internal Planners to provide innovative solutions for managing supply chain challenges (i.e.. constrained supply or expensive comparators).
- Provides clinical supply expertise and internal collaboration within GCSC and for cross functional teams.
ACCOUNTABILITIES:
- 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 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.
- Interfaces with GCSC technology and digital team to understand IRT standards and Smart Supplies 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 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.
- Independently interfaces with Clinical Operations and Regulatory Affairs on information required for Health Authority Submissions
- Evaluate and proposed 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.
DIMENSIONS AND ASPECTS:
- Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
- Clinical Trial Material (CTM) - thorough understanding of the clinical packaging and labeling process supporting R&D in the U.S and abroad. Thorough knowledge of the phases and processes within the clinical development environment
- Product Knowledge – able to understand medical/therapeutic impact of products; understanding of potential product applications
- Regulatory Knowledge– understands current good manufacturing practices (cGMP), current good clinical practices (cGCP) and ICH guidelines as applicable to the packaging, labeling, and distribution of CTM
- Industry Knowledge – Understanding and working knowledge of the overall drug development and clinical development process in a globally operating enterprise, including an in depth knowledge of clinical protocol design, clinical packaging procedures and processes and an in depth knowledge of the investigational material supply chain
- Regulatory inspection experience desirable.
Leadership
- Develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda’s goals and objectives
- Demonstrated ability to manage up and down the organization and ability to lead virtual teams
- Demonstrated ability to influence and negotiate people in a multi-disciplinary team environment
- Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
- Ability to capture knowledge within the organization
- Improves solutions, processes, and deliverables through use of information
- Improves information capital by contributing experience, theories, deliverables, and models for others to use
- Ability to review systems, processes and policies to ensure compliance with required good manufacturing and clinical practices
- Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals.
- The ability to handle many conflicting priorities is critical to build and maintain credibility and respect across the many different constituents in the supply chain
- Ability to expresses one’s self clearly and concisely to stakeholders and business partners over the phone or with others within team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience.
- Coordinates and develops partnerships with key stakeholders to ensure effective communication and on-time delivery of global CTM.
- Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
- Encourages new ideas and innovative approaches in order to continually improve processes
- Develops creative solutions to difficult problems
- Eager to take risks; is not afraid to take risks
- Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- Asks for and provides the right amount of info to meet the needs of management, direct reports & project teams
- Provides team members with timely, constructive feedback, coaching & support to help them recognize and take action on their strengths and development needs
- Demonstrates strong stakeholder service skills.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Scientific/Technical Degree (e.g., Pharmacy, Biology, Chemistry, Engineering), or significant job related
- Minimum of 6 years relevant Pharmaceutical Industry and/or Contract/Service Provider experience is preferred.
- Experience with Medical Devices a plus.
- Strong understanding of cGMP requirements
- Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus.
Locations
Lodz, Poland
Base Salary Range:
zł208,000.00 - zł286,000.00
For information about our benefits, please click here.
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
