Senior Manager, Process Optimization

Otsuka Pharmaceutical Co., Ltd.•Princeton, NJ

23h•$150,034 - $224,250

About The Position

The Senior Manager, Process Optimization is part of the Center of Excellence (CoE) for Trial Operations and works under the direction of the Associate Director/Director, Clinical Operations. The role executes strategic initiatives to enhance operational efficiency, quality, and scalability across clinical trial execution. It designs, implements, and optimizes processes, tools, and systems that support global clinical operations, while collaborating across functions to advance continuous improvement, standardization, and innovation in alignment with regulatory requirements and organizational goals. As a key contributor to operational excellence across the clinical development portfolio, the Senior Manager supports the adoption of standardized practices, measures process performance, partners with internal and external stakeholders, and helps lead change initiatives. The role also ensures process optimization work aligns with GCP, ICH guidelines, and applicable regulatory requirements.

Requirements

Bachelor’s degree in life sciences, business, or a related field.
At least 6 years of experience in clinical operations, process improvement, or operational excellence within the pharmaceutical or biotech industry.
Strong knowledge of clinical trial processes, regulatory requirements, and industry best practices.
Proven experience in process design, Lean Six Sigma, or similar methodologies.
Excellent analytical, project management, and communication skills.
Ability to work independently, lead cross-functional initiatives, and drive organizational change.
Proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
Willingness to travel as required.

Nice To Haves

Advanced degree.
Lean Six Sigma or similar methodology certification.

Responsibilities

Implement process improvement initiatives across clinical operations and Clinical Management.
Evaluate existing workflows and systems to identify inefficiencies and recommend scalable, compliant solutions.
Engage stakeholders to gather insights and feedback and identify optimization opportunities for Clinical Management and cross-functional trial-conduct processes.
Facilitate development of process maps, SOPs, work instructions, and training materials.
Support adoption of standardized processes and best practices across global teams developed by the Clinical Operations CoE.
Serve as a subject matter expert in operational excellence, providing guidance and mentorship to cross-functional stakeholders.
Document processes and contribute to training materials to promote innovation and quality.
Define and monitor KPIs and metrics to assess process effectiveness and operational health.
Analyze performance data to identify trends, gaps, and opportunities for improvement.
Prepare analyses and summaries and support presentation of findings and recommendations to senior leadership.
Partner with cross-functional stakeholders to align and integrate process improvements.
Collaborate on the development and refinement of joint processes, tools, and systems to improve operational efficiency and compliance.
Support cross-functional working groups and governance forums focused on operational excellence.
Partner with external service providers, including CROs, technology vendors, and consultants, to align on optimization goals and ensure consistent execution of outsourced activities.
Support the development and execution of change management strategies to encourage adoption of new processes and systems.
Engage stakeholders to gather feedback, build consensus, and support implementation of initiatives.
Promote stakeholder engagement through communication, training, and support to encourage behavioral change and sustained adoption.
Implement effectiveness checks, such as post-implementation assessments, stakeholder feedback loops, and performance audits.
Use data-driven insights to refine change strategies and support continuous improvement.
Maintain a continuous improvement roadmap aligned with organizational priorities and regulatory expectations.
Ensure process optimization efforts comply with GCP, ICH guidelines, and applicable regulatory requirements.
Collaborate with internal teams to support QMS CAPA implementation related to operational process improvements identified through audits and inspections, as applicable.