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Job Description

Objectives/Purpose:

Global Development Compliance collaborates with R&D Quality and GCP Functions to ensure quality and compliance in clinical development. We drive GCP continuous improvement (“GCP CI”), foster innovation, and maintain a robust, inspection-ready clinical development model. By leveraging technology and automation, we enhance efficiency, streamline processes, and expedite the delivery of medicines to patients.

The Senior Manager, Innovation & Change Management contributes to the strategic implementation of the GCP CI Improvement Framework, focusing on continuous improvement in clinical delivery. This role involves effectively managing projects, cultivating key stakeholder relationships, and developing change management strategies for initiatives. The Senior Manager actively contributes to strategic discussions, providing insights and innovative solutions to enhance operational effectiveness. This position involves collaborating with cross-functional teams, managing risks, and fostering a culture of innovation and continuous improvement.

Accountabilities:

Drive activities to operationalize the GCP CI Framework and implement GCP CI change management initiatives, enhancing clinical delivery and continuous improvement efforts.

Develop and execute change management strategies, ensuring transparent and actionable plans for successful project implementation, and supporting user community readiness and adoption.

Collaborate with cross-functional stakeholders to promote alignment and a culture of continuous improvement.

Proactively identify and mitigate risks and dependencies, ensuring that initiatives are aligned with strategic objectives and deadlines

Regularly assess the effectiveness of change initiatives, integrating lessons learned to improve project delivery.

Engage actively with teams to maintain alignment with strategic goals and ensure seamless cross-functional operations.

Reinforce quality oversight and compliance by implementing effective change management tactics and supporting project objectives.

Core Elements Related to this Role:

Industry Experience: Practical experience in pharmaceutical R&D and clinical trials, with a focus on implementing compliance solutions.

Project and Change Management Expertise: Proven ability to manage projects and change initiatives that drive improvements across people, process, data and technology.

Leadership and Influence: Demonstrated ability to guide teams and positively influence cross-functional initiatives, fostering collaboration and strategic alignment across the organization.

Effective Communication: Excellent communicator, capable of conveying ideas and data both verbally and in writing, ensuring effective stakeholder engagement.

Strategic Insight: Ability to contribute insights to organizational change efforts and align initiatives with departmental goals.

Proactive Innovation: Identify practical solutions and respond to shifts in the regulatory and business landscape, encouraging innovative practices.

Cultural Leadership: Model respect and inclusion, enhancing a culture of collaboration and continuous improvement within teams.

Global Perspective and Adaptability: Operate effectively within global teams, understanding and integrating diverse perspectives, and navigating ambiguity successfully.

Education and Professional Requirements:

BS, MS, or equivalent, with a minimum of 8+ years in program/project management

Minimum of 2+ years in clinical delivery within the pharmaceutical or biotechnology fields.

Program and Change Management:

At least 3+ years of change management experience, leading complex, multi-disciplinary initiatives and aligning multiple stakeholders.

Technical and Industry Knowledge:

Solid knowledge of clinical trial management and GCP compliance.

Proficient in utilizing Microsoft Office and project management software.

Problem Solving and Influence:

Expertise in problem-solving, negotiations, and stakeholder team building.

Demonstrated ability to influence strategic outcomes and solve problems effectively.

Ability to explain and advocate for design thinking to stakeholders.

Communication and Relationship Management:

Proven communication skills, able to present information clearly across organizational levels, including executive management.

Experience in stakeholder relationship management, influencing key projects and ensuring vision realization.

Operational and Leadership Skills:

Experience with matrix organizations and strategic projects, demonstrating strong business acumen and enterprise knowledge.

Ability to adapt and align with virtual/agile teams, managing change effectively in a global context.

Stress Management and Adaptability:

Ability to function well under pressure and in a changing environment, demonstrating adaptability and resilience.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$133,000.00 - $209,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

LocationsMassachusetts - Virtual

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.