Director, Clinical Operations

Job Title: Director, Clinical Operations Department: Clinical Operations Location: On-Site 4 days per week at our Menlo Park, CA, Miami, FL or Princeton, NJ office. About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Director of Clinical Operations will serve as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit. This role should demonstrate strong matrix management skills, confidence in working independently, and have proven ability to champion a team to deliver on key study milestones. In addition, the Director will be responsible for assisting in study design, planning, and execution of clinical trials while operating within budget and per established timelines, regulatory and quality standards. Role and Responsibilities: Study Execution: Oversee and manage the execution of one or more phase 1-3 clinical trials. Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution. Study Planning and Management: Establish and coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables. Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget. Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend Project Team and/or Executive Team Meetings, as required. Study Site Management: Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies. Clinical Trial Budgeting: Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date; identify and communicate discrepancies. Quality Control: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations. Supply Chain Management: Support clinical and non-clinical supplies planning for trial execution. All other duties as assigned. Experience, Education and Specialized Knowledge and Skills: BA/BS required: scientific/medical field preferred. A minimum of 1+ years of experience in managing global clinical trials at all stages of development. Oncology clinical trial experience strongly preferred. Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities. Demonstrated successful management and oversight of CROs and other service providers. Deep understanding of clinical trial design, protocol development/review, and running the clinical trial meetings. Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities. Experience organizing and/or participating in specific study-related advisory committees (e.g., steering committee, data monitoring committees, adjudication committees). Experience in the management and maintenance of EDC, CTMS, IxRS, ePRO, etc. Experience in SOP and Study Plans writing, CAPA preparation, and closure. Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities. Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations. Strong project management experience and skills is preferred. Strong leadership and matrix management skills; ability to multi-task in a dynamic and fast-paced environment. Excellent written & verbal skills and proven interpersonal, negotiation, influencing, problem-solving skills. Willing to travel domestically and internationally up to 20% of the time. Proficient user of standard MS Office suite (e.g., Word, Excel); experience using electronic document management systems, and document review tools desirable. Critical thinking, problem solving, ability to work independently. Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. The pay range for this role is $197,000 $230,000 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. #J-18808-Ljbffr