Job Details

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan, dedicated to addressing patient needs through innovative solutions in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With an extensive range of marketed products and a dynamic pipeline of investigational assets, we are committed to accelerating research and development to deliver groundbreaking therapies to patients sooner.

Job Overview

The Senior Director of Clinical Operations plays a crucial role in our Clinical Operations leadership team. This individual will be instrumental in implementing Risk-Based Quality Management, Operational Data & Analytics, Records Management, and Inspection Readiness Strategies across all clinical studies from Phase 1 to Phase 4. We seek a strategic leader who is well-versed in all aspects of clinical trials operations, Good Clinical Practice (GCP), and relevant regulatory guidelines.

Key Responsibilities

• Ensure all studies are monitored in compliance with regulatory standards, utilizing risk-based quality management techniques and best practices from SMPA.

• Collaborate with cross-functional teams to define and put into action risk-based monitoring strategies including risk assessment methods and centralized monitoring approaches.

• Develop targeted oversight strategies for CRO monitoring practices and act as an escalation resource for study teams.

• Maintain expertise in systems and technology related to central monitoring analytics and operational data; advocate for the design of innovative systems that align with company objectives.

• Lead initiatives and process improvements within the department, ensuring clinical operations are enhanced and effectively integrated into cross-functional initiatives.

• Oversee the development and maintenance of departmental SOPs, best practices, and tools.

• Support stakeholder teams in preparing inspection readiness processes and materials; may represent Clinical Operations during audits and inspections.

• Manage the Clinical Records Management team (Trial Master File) with strong leadership.

• Oversee budgeting for the clinical operations department and relevant vendor budgets.

• Guide and mentor direct reports to foster their professional development and ensure effective execution of their responsibilities.

Core Competencies

• Deep understanding of clinical development principles and the pharmaceutical industry standards, including GCP and ICH Guidelines.

• Expertise in clinical operations monitoring, CRO processes, and collaborating with leading CROs.

• Visionary capabilities in risk-based quality management, analytics, and visualizations related to clinical trial performance and compliance.

• Strong experience in implementing and maintaining systems that support Clinical Operations, particularly eTMF and Operational Data Modeling systems.

• Exceptional communication skills across global partnerships, executive leadership, and technical teams.

• Innovative approach to creating applicable solutions and processes.

• Experience in clinical compliance and developing inspection readiness protocols.

• Proven leadership in a collaborative team environment.

• Ability to navigate diverse personalities and maintain productive team dynamics.

• Strong organizational awareness and a comprehensive understanding of interdependent functions.

Education and Experience

• Bachelor's or advanced degree in life sciences, pharmacy, or a related field.

• 15-20 years of experience in the biotech or pharmaceutical industry without a Master's degree, or 10-15 years with a Master's degree.

Compensation

The base salary for this role ranges from $222,320 to $277,900. This salary is a part of our total rewards package, which includes merit-based salary increases, access to our 401(k) plan, and various insurances. Our time-off policy includes flexible paid leave, 11 paid holidays, additional time off during year-end shutdown, and sick leave benefits. Total compensation will be tailored to each candidate's unique qualifications and experience.

Mental/Physical Requirements

The role requires working in a fast-paced environment with multiple priorities. Candidates should have strong judgment, initiative, and independence. Excellent written and verbal communication skills are essential, along with the ability to use a personal computer for prolonged periods.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. We value diversity and are committed to providing employment opportunities without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, disability, veteran status, or any other characteristic protected by law.