Summit Therapeutics, Inc.
Senior Director, Clinical Operations (TMF & CTMS)
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Senior Director, Clinical Operations (TMF)
Ivonescimab, also known as SMT112, is a novel investigational bispecific antibody combining PD‑1 blockade with anti‑angiogenesis via VEGF blockade. Summit has begun clinical development of ivonescimab in non‑small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi – evaluate ivonescimab plus chemotherapy vs placebo plus chemotherapy in EGFR‑mutated, locally advanced or metastatic NSCLC progressed after 3rd‑generation EGFR TKI. HARMONi‑3 – evaluate ivonescimab plus chemotherapy vs pembrolizumab plus chemotherapy in first‑line metastatic NSCLC. HARMONi‑7 – evaluate ivonescimab monotherapy vs pembrolizumab monotherapy in first‑line metastatic NSCLC with high PD‑L1 expression. Ivonescimab is an investigational therapy not approved in Summit’s license territories, including the United States and Europe. It was approved for marketing in China in May 2024 and granted Fast Track designation by the FDA for the HARMONi clinical trial setting.
Overview Of Role
The Senior Director, Clinical Operations (TMF) leads and optimizes the delivery of the next‑generation integrated platform for clinical trial operations and document management systems. The role focuses on people, process, and technology, driving effective and efficient processes that meet high compliance standards and implementing new systems and practices. Role And Responsibilities
Develop, implement, and oversee the CTMS and TMF systems and related processes. Lead the oversight of TMF and CTMS vendors, contractors, and cross‑functional teams. Provide leadership and development to existing TMF employees, leading by example and demonstrating core values. Define, execute, and communicate the strategic vision for TMF and CTMS to maximize end‑user focus and engagement. Partner with key internal and external stakeholders to remediate risks and manage emerging issues. Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards. Provide business‑level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations. Lead a team of TMF and CTMS colleagues and ensure their continuous development. Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals. Keep current on changes in industry and regulatory standards for GCP requirements and advise on business impact for TMF and CTMS. Provide strategic leadership, insight, and guidance as an active member of the Clinical Operations Extended Leadership Team (XLT). Ensure inspection‑ready TMF and CTMS and provide expert support for audits and inspections. Instill a culture of continuous improvement; act as a change champion and effectively lead change. Other key assignments including ad‑hoc and stretch assignments in support of Clinical Operations and clinical trial execution. Travel on assignment (~25%). All other duties as assigned. Experience, Education And Specialized Knowledge And Skills
Bachelor's degree (e.g., BA, BS or equivalent) required; preferably in life sciences. A clinical or advanced degree in a science, health‑related, or industry related discipline is preferred. Minimum of 12+ years of experience with a pharmaceutical company and/or CRO, with increasing levels of responsibility in Clinical Operations in a global environment. A minimum of 5+ years of experience in people management/leadership required. Proven line and functional manager experience, able to effectively lead teams including regional (multi‑country) and remote‑based staff. Experience in Phase III execution of clinical trials; oncology trials preferred. Previous regulatory inspection experience preferred. Strong comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines. Significant vendor oversight experience including contracts and budget management preferred. Pay range: $230,000 - $250,000 annually. Compensation packages may additionally include bonus, stock, benefits, and other variable compensation based on skill set, experience, and location.
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Ivonescimab, also known as SMT112, is a novel investigational bispecific antibody combining PD‑1 blockade with anti‑angiogenesis via VEGF blockade. Summit has begun clinical development of ivonescimab in non‑small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi – evaluate ivonescimab plus chemotherapy vs placebo plus chemotherapy in EGFR‑mutated, locally advanced or metastatic NSCLC progressed after 3rd‑generation EGFR TKI. HARMONi‑3 – evaluate ivonescimab plus chemotherapy vs pembrolizumab plus chemotherapy in first‑line metastatic NSCLC. HARMONi‑7 – evaluate ivonescimab monotherapy vs pembrolizumab monotherapy in first‑line metastatic NSCLC with high PD‑L1 expression. Ivonescimab is an investigational therapy not approved in Summit’s license territories, including the United States and Europe. It was approved for marketing in China in May 2024 and granted Fast Track designation by the FDA for the HARMONi clinical trial setting.
Overview Of Role
The Senior Director, Clinical Operations (TMF) leads and optimizes the delivery of the next‑generation integrated platform for clinical trial operations and document management systems. The role focuses on people, process, and technology, driving effective and efficient processes that meet high compliance standards and implementing new systems and practices. Role And Responsibilities
Develop, implement, and oversee the CTMS and TMF systems and related processes. Lead the oversight of TMF and CTMS vendors, contractors, and cross‑functional teams. Provide leadership and development to existing TMF employees, leading by example and demonstrating core values. Define, execute, and communicate the strategic vision for TMF and CTMS to maximize end‑user focus and engagement. Partner with key internal and external stakeholders to remediate risks and manage emerging issues. Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards. Provide business‑level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations. Lead a team of TMF and CTMS colleagues and ensure their continuous development. Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals. Keep current on changes in industry and regulatory standards for GCP requirements and advise on business impact for TMF and CTMS. Provide strategic leadership, insight, and guidance as an active member of the Clinical Operations Extended Leadership Team (XLT). Ensure inspection‑ready TMF and CTMS and provide expert support for audits and inspections. Instill a culture of continuous improvement; act as a change champion and effectively lead change. Other key assignments including ad‑hoc and stretch assignments in support of Clinical Operations and clinical trial execution. Travel on assignment (~25%). All other duties as assigned. Experience, Education And Specialized Knowledge And Skills
Bachelor's degree (e.g., BA, BS or equivalent) required; preferably in life sciences. A clinical or advanced degree in a science, health‑related, or industry related discipline is preferred. Minimum of 12+ years of experience with a pharmaceutical company and/or CRO, with increasing levels of responsibility in Clinical Operations in a global environment. A minimum of 5+ years of experience in people management/leadership required. Proven line and functional manager experience, able to effectively lead teams including regional (multi‑country) and remote‑based staff. Experience in Phase III execution of clinical trials; oncology trials preferred. Previous regulatory inspection experience preferred. Strong comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines. Significant vendor oversight experience including contracts and budget management preferred. Pay range: $230,000 - $250,000 annually. Compensation packages may additionally include bonus, stock, benefits, and other variable compensation based on skill set, experience, and location.
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