VP Clinical Development, Oncology

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview 

We are seeking an experienced VP Clinical Development, Oncology to fulfill a critical and highly visible role to help shape the future of development at SMPA. This role is responsible for the successful strategic positioning and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory, Early Clinical Development, Pre-clinical research, Medical Affairs and Commercial functions. The VP Clinical Development, Oncology will be responsible for leading and designing clinical programs in Oncology at SMPA.  

The ideal candidate will need deep expertise in Oncology with strong leadership skills, scientific rigor, and the ability to collaborate effectively with cross-functional teams. The VP Clinical Development, Oncology is expected to cultivate relationships with scientific leaders and serve as an outward-facing representative of the company to the scientific community.  This role will report to the Chief Medical Officer- Oncology and will have functional responsibility for all clinical development activities in Oncology across all stages of development. 

Job Duties and Responsibilities

Overview

• Strategic Leadership: Lead the strategic and clinical direction of the cross-functional teams from preclinical experiments to the end of the product’s life cycle.  
• Clinical Trial Oversight: Develop and oversee clinical trial strategies, ensuring alignment with corporate objectives and regulatory requirements for SMPA and the future oncology initiatives. 

• Medical Expertise: Deep knowledge and expertise in Oncology, scientific rigor and understanding of the different cross functional teams to interact for the best outcomes for SMPA.

• Team Management: Lead and coordinate cross-functional teams to drive collaboration, enhance productivity and achieve goals effectively. 
• Regulatory Engagement: Interface with regulatory authorities, including the FDA, EMA, and other global agencies, to secure trial approvals and navigate the regulatory landscape. 

• Data Analysis and Reporting: Oversee data interpretation, ensuring accurate and timely reporting to internal stakeholders, regulators, and the scientific community. 

Strategic Leadership:

• Provide medical vision and clinical leadership for the strategy and plan to advance SMPA’s current and future product portfolio
• Develop and execute the overall clinical development strategy for Oncology, aligning with SMPA’s overall goals and regulatory requirements. 
• Lead the medical and scientific aspects of clinical trials, including protocol design, study endpoints, and data analysis. 
• Provide medical expertise to cross-functional teams, including regulatory, commercial, and clinical operations. 
• Provide day-to-day practical and overarching strategic guidance for Oncology clinical programs, ensuring that the design, implementation, and conduct of the clinical studies provide unambiguous data and information that allows for clear decision making and advancement of development efforts. 

Clinical Trial Oversight:

• Manage the full lifecycle of clinical trials, from feasibility assessment and site selection to data analysis and reporting. 
• Provide leadership to cross-functional teams to create scientifically rigorous and innovative trial protocols.
• Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. 
• Develop and execute corporate clinical strategy for global development projects in Oncology
• Monit