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Job Description

OBJECTIVES/PURPOSE

The mission of the Process, Training and Digital Solutions within Innovation & Data is to drive innovative ways of working to enable a fit-for-purpose clinical trial delivery operating model. We bring together people, process, data and technology with a focus on continuous improvement to deliver medicines to patients faster.

The Associate Director, Training Development and Delivery will lead the development and delivery components of the end-to-end clinical trial delivery training model. This includes partnering with the stakeholders (internal and external) and functional leadership to assess, define, develop and implement novel training delivery methods for adult learning to enable agile and effective clinical trial execution and ensuring regulatory compliance.

ACCOUNTABILITIES

The Associate Director, Training Development and Delivery responsibilities include :

• Advise/strategize with Training Development and Delivery and PTDS leadership on the end-to-end clinical trial delivery training strategy

• Lead and/or manage analysis, design, development and implementation of high quality, high value training programs in alignment with functional area goals and initiatives

• Develop new hireoperating model training orientations for internal and external stakeholders; Deliver and/or oversee delivery of orientation to new employee on defined training curricula including overview of training systems

• Maximize clinical trial delivery process efficiency and regulatory compliance by managing and overseeing GxP training and operating model training compliance for supported functional areas

• Lead and/or manage the development of clinical trial delivery training plans: Ensure relevant training plans are available in Learning Management System (LMS) and/or relevant on the job training tools for supported functional areas

• Leverage training technology solutions to deliver innovative learning approaches to support hybrid ways of working

• Partner with Process, Training and Digital Solutions Innovation & Change Management to develop and manage communications related to training (e.g., GxP, operating model, skill development,compliance etc.)

• Lead and/orparticipate in clinical trial delivery supported functions on company-wide/R&D-wide training initiatives

• Active participation on Quality training forums and process improvement activities

• Serve as clinical trial delivery training SME for inspections and internal audits

• Lead and/or participate in training development efforts for implementation of systems, global initiatives etc.

CORE ELEMENTS RELATED TO THIS ROLE

• Experience with the pharmaceuticalindustry, including research and development and especially clinical trials conduct.

• Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle

• Knowledge of drug development and clinical trial processes, including related standards and documents.

• Proven conceptual thinking and strategic problem-solving ability

• Ability to prioritize and lead various team members at various levels to achieve goals

• Serve as a role model, demonstrating respect and inclusion, creating a culture that fosters innovation

• Proven ability to adapt to change and manage cultural change in an evolving environment.

• Work in a global ecosystem (internal and external) with a high degree of complexity including geographically distributed team members and experts with different cultural backgrounds and deep level expertise

• Ability to build strong relationships and collaborate with other interfacing Takeda functions, including senior leadership

• Recognize opportunities for improved goals and implement innovative approaches

• Effectively negotiate and resolve conflicts in a constructive manner

• Ability to understand highly complex problems and be able to apply effective and innovative solutions to them.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

• BS, MS or equivalent in scientific field

• Minimum of 8+ years experience in pharmaceutical, CRO, healthcare or related industry

• Minimum of 3+ years experience with training development for clinical trial delivery or equivalent

• Solid understanding of US CFR, GCP, ICH regulations and the clinical development process

• Experience with implementing novel training approaches in adult learning setting

• Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required

• Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving

• Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management

• Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and project teams to turn vision into reality.

• Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects

• Excellent oral and written communication skills, business acumen, and enterprise knowledge.

• Work with virtual/agile teams in different locations, aligning and adapting different work, culture, and communication styles.

• Effectively communicate complex problems and proposed solutions across various levels of the organization

• Function well under pressure in a changing environment

• Experience with training authoring tools suchasArticulate or Captivate

• Experience collecting and assessing learning metricsusingindustry standard models suchasKirkpatrick's

• Experience project managing training development & delivery projects

ADDITIONAL INFORMATION

• This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

• Base Salary Range: $143,500 to $205,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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