Director Clinical Supply Chain Operations

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Job Description

ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).

• Liaise between GCSC Planning and China and/or Asia Development Teams (CDT/ADTs) to equip Planning Lead with data, scenarios, and judgements for meaningful planning and strategy discussions with Global Clinical Teams (GCTs) and Clinical Sub teams (CSTs) for China programs.

• Responsible for developing best practices and leading indicators for successful planning and execution in China and the APAC region. Responsible for providing boots-on-the-ground perspectives and troubleshooting when necessary and incorporating learnings and root cause analysis into improved best practices.

• Lead operational feasibility assessment, scenario analysis and risk mitigation for China and the APAC region clinical protocols. Advise global CMC teams, Clinical Sub teams, and Planning Lead in the development of operational feasibility assessments, scenario analysis, and risk mitigations specific to the China and the APAC region components of development programs

• Responsible for advising and troubleshooting integrated strategy and management of clinical trial materials (investigational medicinal product(s) and comparator) for programs in China and the APAC region.

• Responsible for addressing China and the APAC region specific stakeholder requirements from multiple internal and external functions including Clinical Operations, Pharmaceutical Sciences, and Procurement disciplines.

• Provides input into Interactive Response Technology (IRT) design for randomization, supplying CTM to depots and sites, and for return functionality.

• Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of IMP for shipment to sites.

• Works closely with Logistics function to pro-actively plan, document, and facilitate cross-border supply strategies, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.

• Coaches, and mentors less experienced staff personnel and act as a role model for Takeda’s values.

CORE ELEMENTS RELATED TO THIS ROLE: (Describe what is critical and/or what differentiates this role).

• Excellent communication skills in English and Chinese, organizational, and team collaboration skills.

• Strong project management skills and ability to work effectively through change and fluid timelines

• Must be able to handle multiple projects simultaneously while maintaining high quality results.

• Must provide and implement innovative solutions to unique situations related to supply and re-supply of IMP for our patients in China and the APAC region.

• Must be able to recognize potential conflict and escalate in a timely fashion when necessary.  

• Presentation Skills- ability to give professional and concise presentations at internal and external stakeholder meetings

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 China and the APAC region. Thorough knowledge of the phases and processes within the clinical development environment.

• Product Knowledge – able to understand medical/therapeutic impact of IMPs and understanding of potential product applications.

• Regulatory Knowledge– understands "good practice" (GXP) quality guidelines and regulations for Manufacturing (GMP), Clinical (GCP), Distribution (GDP) and ICH guidelines as applicable to the packaging, labeling, and distribution of CTM in China and the APAC region.

• Creates functional strategies and goals that are closely aligned with Takeda’s objectives and develops metrics to track and assess performances and an in-depth knowledge of the investigational material supply chain.

Job Description / Role Profile

Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda’s goals and objectives. 

• Demonstrated ability to influence and negotiate with people in a multi-disciplinary team environment.

• Develops and communicates a convincing business case for change that motivates stakeholders to take action.

Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

• Improves solutions, processes, and deliverables through use of information and data.

• 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, clinical, and distribution practices.

• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

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 clinical supply chain.

• Ability to express oneself clearly and concisely to stakeholders and business partners over the phone
  or with others within team; documents issues and/or concerns concisely, comprehensively and in a timely

manner. 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 CTM.

• Creates a clear and unifying vision that inspires the team to excel.

Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

• Encourages new ideas and innovative approaches to continually improve processes.

• Develops creative solutions to difficult problems.

• Displays strong innovative capabilities.

• Eager to take risks; not afraid to take risks based on sound risk management methodology.

Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

• Asks for and provides the right amount of information to meet the needs of management, direct reports & project teams.

• Provides team members with timely, constructive feedback, coaching & support to help them recognize and act on their strengths and development needs.

• Demonstrates strong stakeholder service skills.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

• 8-12 years relevant Pharmaceutical Industry and/or Contract Provider experience is preferred with a minimum of 5 years of experience in Clinical Supply Chain.

• Leadership skills and strategic problem-solving ability; ability to predict, anticipate issues and identify solution(s). Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously.

• Experience with Medical Devices and ancillary supplies a plus.

• Expert understanding of clinical supply unit operations within planning and operations, as well as supply/demand forecasting.

• Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus

• Strong technical background with GMP, GDP (Good Documentation Practice) experience.

• Excellent communication skills in English and Chinese; fluent written and spoken Mandarin and experience in presenting technical topics to non-expert and executive audiences

• Strong project management skills and ability to work effectively through change and fluid timelines.

• Ability to balance enterprise perspective with study and project-level deliverables.

• Ability to simultaneously manage multiple tasks of varied complexity and spanning from big picture strategy to detailed tactics.

• Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs.

• Ability to work effectively with decentralized teams and maintain working relationships with limited face to face interaction with team members located in different countries.

• Ability to influence stakeholders from many technical disciplines and at many levels.

Locations

Shanghai, ChinaBeijing, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time