Associate Director, Clinical Operations
About The Position
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 eg osimertinibHARMONi 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 NSCLCHARMONi 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 expressionIvonescimab 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 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 Summits 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
- Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other healthmedical related area preferred
- 10 years of clinical project management experience in conducting international clinical trials in sponsor PharmaBiotech organization
- A minimum of 5 years of phase II and III combined experience required
- Strong understanding of the drug development process ICH guidelinesGCP 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 memberscolleagues
- 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 eg 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 CROs to ensure robust patient enrollment strategies are developed and carried out effectively and on time
- Partners with CROs 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 includingInvestigator agreements CTA CRFs CRF guidelines statistical pharmacokinetic analysis plans monitoring plan data management and safety monitoring
- Reviews CROs and vendor contractswork 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
