Summit Therapeutics Plc Miami , FL 33196
Posted 6 days ago
Our Mission:
To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
Summit Activities:
We have in-licensed ivonescimab (SMT-112), which 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 taking advantage of cooperative binding between the two. We initiated multiple phase-III clinical studies in the following Lung cancer indications:
Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
Overview of Role:
Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Role and 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
Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
Partners with the CRO 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, safety monitoring
Responsible for reviewing CRO 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. 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 Trial Associates allocated to the project
Experience, Education and Specialized Knowledge and Skills:
Bachelors degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
8+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
Prior phase II and III experience required
A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Experience with budget forecasting and management
Experience with clinical studies in oncology
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
Experienced and enjoys 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 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
Experience in working in a small organization
Excellent written and oral communication skills
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
Strong computer and database skills
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
Excellent organizational skills
Critical thinking, problem solving, ability to work independently.
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting demands.
Work in a fast-paced, demanding and collaborative environment
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits human resources department to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Plc