at Takeda Pharmaceuticals in Montpelier, Vermont, United States
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.
As the Director of Clinical Trial Training Development & Delivery, you will provide global leadership and direction for clinical trial delivery training strategy in partnership with R&D Quality Assurance (QA). You will report to the Head of Process, Training and Digital Solution Management. Effective management of the clinical trial delivery training strategy will require significant collaboration with stakeholders and functional leaders across R&D. The Clinical Trial Training Development & Delivery team will lead and manage the end-to-end clinical trial delivery training framework. 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.
The Director of Clinical Trial Training Development & Delivery is expected to:
+ Oversee and manage direct reports and functional service provider resources creating a culture that fosters people development, inclusion, and innovative ways of working
+ Partner with Process, Training and Digital Solutions and functional leadership to develop the end-to-end strategy for incorporating Future Fit ways of working to enable the clinical trial delivery operating model (analyze, design, develop, implementation, adoption, change management etc.)
+ Develop framework and enable capabilities to analyze, design, develop and implement high quality high value training programs for clinical trial delivery; Focus on novel and agile approaches for adult learners
+ Develop and oversee the clinical trial delivery GxP training curricula within Learning Management Systems (LMS) to ensure appropriate training for all roles; liaise with functional area leadership to ensure compliance
+ Oversee development and delivery of clinical trial delivery onboarding orientations for new employees including GCP training curricula
+ Leverage training technology solutions to deliver innovative learning approaches to support hybrid ways of working
+ Work with R&D QA, functional leaders and stakeholders (internal and external) to ensure business impact is well-understood and accountabilities training strategy
+ Partner with Innovation & Change Management to drive optimization activities and initiatives for global clinical trial delivery functions including communication with stakeholders and customers as it relates to training
+ Serve as a clinical trial delivery representative on R&D Training Governance
+ Represent clinical trial delivery supported functions on company-wide/R&D-wide training initiatives
+ Actively participate in Quality training forums and process improvement activities
+ Serve as clinical trial delivery training SME for inspections and internal audits
+ Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners
+ Provide strategic vision for long-term delivery innovation to continuously optimize ways of working
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
+ BS, MS or equivalent
+ Minimum of 10+ years in training development and delivery experience
+ Minimum of 3+ in pharmaceutical, CRO, healthcare or related industry
+ Knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle
+ Demonstrated experience of leveraging technology to deliver effective training in a hybrid workplace
+ Solid understanding of US CFR, GCP, ICH regulations and the clinical development process
+ Experience in problem solving, negotiations and collaborative team building with 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
+ Understand design thinking and can explain and convince stakeholders
+ Work with virtual teams in different locations, aligning and adapting different work, culture, and communication styles
+ Function well under pressure in a changing environment
Base Salary Range: $160,300 to $229,000. 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.
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.
Massachusetts – Virtual