Director, Business Process Optimization - Cambridge, MA or Remote

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The Director, GRA Business Optimization will report to the Head of Business Optimization and Regulatory Chief of Staff and lead Takeda Global Regulatory Affair optimization group. This includes driving and leading overall management, direction, coordination, and implementation of high priority change initiatives designed to optimize business processes critical to the operational effectiveness of Takeda. In this role the individual will collaborate across multiple stakeholders in identifying and validating opportunities, develop and manage the right teams and plan to execute, and track and report on progress and success metrics for the selected initiatives.

RESPONSIBILITIES:

• Lead a team of stakeholders to review processes/practices of strategic business importance in order to identify inefficiencies and/or areas of opportunity for improvement; be comfortable in challenging existing practices and develop innovative solutions that aim at increasing operational efficiencies
• Provide leadership, direction, and overall oversight for the continuous improvement of products and processes as well as new initiatives aligned with Takeda strategy
• Manage and prioritize the portfolio of initiatives based on business impact and investment required, through collaboration with all levels of the organization; manage process improvement initiatives that are measurable and drive value for the organization
• Develop and manage processes to identify any areas of opportunity and potential hurdles supporting the organization's strategic plans and objectives
• Identify continuous improvement opportunities throughout the organization by imploring opportunity analysis, and reviewing metrics
• Partner cross-functionally to understand demand and drive opportunities for scoping and prioritization across the simplification initiatives
• Develop and maintain appropriate tools/dashboards and establish key metrics to provide visibility on Initiative milestone progress and capacity
• Initiate and lead discussions to facilitate the refinement of the project scope, goals, and deliverables and identify appropriate team actions and risks
• Create and manage the knowledge repository and project artifacts during all phases of the project (eg, charter, project plan, close out report, etc.)
• Develop and maintain a roadmap of process improvement opportunities including statements of work and resource allocations required to manage project workload demands
• Manage resources and vendors that provide project support and ensure they are effectively onboarded, managed, and delivering on expected milestones
• Identify and deploy tools and techniques to improve efficiency and effectiveness of all processes and operations
• Engage teams to help establish a continuous improvement culture and execute advanced problem-solving activities
• Oversee and mentor direct reports, providing leadership and training to support professional development and responsible for demonstration of Takeda Leadership Behaviors

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry and 10+ years of experience in one or more of the following areas: clinical development operations, pharmacovigilance, regulatory affairs, or pharmaceutical supplies
• Project management expertise, demonstrated ability to lead multiple, complex projects from inception to close-out

Leadership

• Demonstrated ability to work across functions, regions and cultures
• Functional level leadership with the ability to inspire, motivate and drive results
• Outstanding communicator, able to persuasively coney both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distil complex issues and ideas down to simple comprehensible terms
• Demonstrates senior leadership presence and confidence
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
• Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on-key organizational initiatives
• Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

• Provide input to highly complex decisions that impacts across functional areas
• Accountable for decision making for designated function
• Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
• Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
• Accountable for providing inception of and implementing vision and strategy for designated scope

Interaction

• Expertly navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise
• Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

• Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to take risks implementing innovative solutions, accelerating time to market
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
• Role models respect and inclusion, creating a culture that fosters innovation

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity

• Deep expertise required
• Ability to see and understand broader, enterprise level perspective

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.)

• Bachelor's degree or related experience is required. Scientific or closely related field preferred; Advanced degree preferred
• 10+ years of experience in the pharmaceutical/biotechnology industry with 8+ years direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies
• Demonstrated experience leading teams, managing and mentoring colleagues
• Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
• Six sigma, LEAN, and/or PMP certification or equivalent desirable
• Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
• Proven track records of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
• Demonstrates leadership, problem-solving ability, flexibility and teamwork
• Exercises good judgement in elevating and communicating actual or potential issues to line management
• Excellent written and oral communication skills required
• Demonstrates leadership, problem-solving ability, flexibility and teamwork
• Exercises good judgement in elevating and communicating actual or potential issues to line management
• Excellent written and oral communication skills required
• Active participation in Agency/Industry groups/forums expected

OFFICE LOCATION:

• Cambridge, MA or Remote

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.