at Takeda Pharmaceuticals in Springfield, Illinois, 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 Associate Director, Process Development and Delivery, reporting to the Director of Process Development and Delivery, you will lead activities for the Clinical Trial Delivery Quality Management System (QMS) Standard Operating Procedure (SOP) development and maintenance in partnership with R&D Quality Assurance (QA). This includes cross-functional collaboration with stakeholders and functional leaders across R&D. You will focus on maximizing clinical trial delivery process efficiency and regulatory compliance by leading SOP/QMS document development and overseeing maintenance for supported functional areas with relevant SMEs, senior leadership, stakeholders, and Quality.
The Associate Director , Process Development and Delivery responsibilities include :
+ Advise/strategize with Process Development and Delivery and PTDS leadership on the end-to-end clinical trial delivery GxP document strategy
+ Lead Quality Management System (SOP) development and maintenance process for supported functional areas with relevant SMEs, stakeholders, and Quality; ensure consistency in document portfolio within QMS
+ Lead the process development and maintenance activities in support the of clinical trial delivery operating model
+ Advise/strategize on the business process owners (BPO)network framework in partnership with PTDS leadership and R&D QA; Oversee facilitation of BPO network (as needed)
+ Maximize clinical trial delivery process efficiency and regulatory compliance by leading process improvement activities and initiatives in global clinical trial delivery functions
+ Partner with Process, Training and Digital Solutions Innovation & Change Management to develop and manage communications related to process and SOP changes
+ Represent clinical trial process leadership on Quality SOP initiatives
+ Serve as clinical trial delivery SOP& Process SME for inspections and internal audits; Participate in the development of inspection strategy in collaboration with GCP Operational Excellence
+ Lead QMS system development and maintenance process for supported functional areas with relevant SMEs, stakeholders, and Quality; ensure consistency in document portfolios
+ Ensures consistency and alignment across interdependent processes to provide holistic oversight
+ Lead and/or participate in process 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
+ Advanced knowledge of drug development and clinical trial processes, including related standards and documents.
+ Experience leading and/or managing business process owners network
+ 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 QMS and process development for clinical trial delivery
+ Solid understanding of US CFR, GCP, ICH regulations and the clinical development process
+ 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
+ Extensive experience in design or in implementing solutions and preferable experience in quality improvement.
+ 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
+ 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.
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