Associate Director, Clinical Operations

Summit Therapeutics Plc•Menlo Park, CA

55d•$168,000 - $198,000

About The Position

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 Summit's 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. The Associate Director, Clinical Operations is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. This position is responsible for study start up and maintenance through study close out. The Associate Director, Clinical Operations will coordinate, lead and drive Summit's cross functional team members, CROs, and vendors to successfully deliver clinical studies. They will be responsible for all performance metrics and quality of deliverables in the clinical trial.

Requirements

Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
10+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
A minimum of 5+ years of phase II and III combined experience required
Strong understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Experience with budget forecasting and management
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%).
Proven proficiency in overseeing large complex studies being managed in house and by a CRO
Demonstrated ability to lead teams and work in a fast-paced team environment
Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
Proven track record of building relationships with KOLs and site personnel
Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
Demonstrated ability to build and deliver on patient enrollment strategies
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives.
Demonstrated ability to comprehend and communicate complex scientific concepts and data
Proficient in reviewing and assessing clinical data
Possesses excellent planning, time management & coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
Strong attention to detail, accuracy and confidentiality
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents

Nice To Haves

Experience with clinical studies in oncology strongly preferred.
Line management (direct reports) experience is preferred.

Responsibilities

Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO, and vendors to ensure that overall project objectives are met
Fosters solid professional relationships with key opinion leaders and clinical site staff
Partners with CRO(s) to ensure robust patient enrollment strategies are developed and carried out effectively and on time
Partners with CRO(s) to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
Proactive identification and management of study related risks
Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
Responsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring
Reviews CRO(s) and vendor contracts/work orders and specifications to enable study objectives to be met
Reviews and approves essential document packages to enable timely site activations
Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
Perform periodic QC of the TMF
Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices (GCP)
Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
Ensures the study is “inspection ready” always
Responsible for oversight and coaching of the functional activities of Clinical Research Associates and Clinical Trial Associates allocated to the project
All other duties as assigned