Job Information
Takeda Pharmaceuticals Director, Clinical Trial Process Development & Delivery - REMOTE in Topeka, Kansas
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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 Director of Clinical Trial Process Development & Delivery is responsible for providing global leadership and strategic direction for Quality Management System (QMS) Standard Operating Model (SOP) development and maintenance strategy for clinical trial delivery in partnership with R&D Quality Assurance (QA). Effective management of the clinical trial delivery process strategy will require significant collaboration with stakeholders and functional leaders across R&D. The Clinical Trial Process Development & Delivery will apply innovative ways of working and encourage new ideas from subject matter experts to maximize clinical trial delivery process efficiency. The team will lead and execute on the end-to-end process development framework. This includes partnering with the Business Process Owners (BPOs) to define and develop standard operating procedure (SOP), process operationalization, content and implementation support and ensure regulatory compliance.
ACCOUNTABILITIES :
The Director of Clinical Trial Process 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.)
Lead SOP capability in support of clinical trial delivery operating model(s) within Takeda QMS
Partner with QA QMS on GxP process development strategy and framework for clinical trial delivery
Oversee execution of the QMS SOP framework for clinical trial delivery; Ensure ongoing engagement of R&D QA, BPOs, stakeholders (internal and external) and functional leadership
Work with R&D QA, functional leaders and stakeholders (internal and external) to ensure business impact is well-understood and accountabilities process strategy are clearly defined
Enable capabilities to maximize clinical trial delivery process definition and development efficiency
Partner with R&D QA to develop strategy and oversee the Process Owner Network Facilitation for clinical trial delivery to ensures consistency and efficient connections
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 process
Serve as the Clinical Trial Delivery Lead on QA QMS Initiatives
Accountable for ensuring process changes are incorporated as required regulation or CAPAs
Serve as clinical trial delivery SOP & Process 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 experience in pharmaceutical, CRO, healthcare or related industry
Minimum of 5+ years experience with QMS and process development for clinical trial delivery
Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle
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.
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
#LI-Remote