Company Summary:

Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.

General Responsibilities:

The Sr. Clinical Trial Associate will provide support Clinical Trial Manager or Director, Clinical Development Operations to implement clinical operation plans to manage all aspects and progress of Clinical Trials. Will partner with other functional areas to make sure studies are in alignment with operational strategy from study start to study close. Will also contribute to department process improvement initiatives.

Specific Responsibilities Include:

• Support the cross functional study team; to ensure study goals and timelines are met with quality and in compliance with SOPs and regulatory guidelines
• Identifies and/or anticipates study issues or risks that will impact budget, resources and timelines and plans accordingly with cross functional team for mitigation and escalates issues as necessary.
• For tasks outsourced to specialty/biomarker laboratories, will oversee and monitor performance for all contracted services to ensure trials and relevant program related activities are in adherence to ICH/GCP, study SOPs, and regulatory guidelines and provide status reports to functional team.
• Maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported.
• Tracks Clinical Trial progress and clinical data (patient status, sample collection, lab results, efficacy reports) against planned timelines
• Provides strategic Clinical Trial input related to study logistics, management, and oversight of enrollment (including forecasting), clinical supply and drug supply, data review and data cleaning, and Trial Master Files.
• Contribute to the development, review and approval of study documents including but not limited to protocol, ICF, multiple Clinical Trial plans, EDC/CRFs, pharmacy manual, oversight manuals, clinical study reports, patient narratives, and Clinical Trial Agreements
• Review monitoring reports, follow up letters and reports from other outside vendors.
• Participate in the development, review and implementation of departmental SOPs and processes.
• Organizes, manages, reviews and in cases where this is outsourced, oversees the Trial Master File to maintain up-to-date regulatory documentation for all research sites
• Oversees reconciliation and transmittal of essential documentation to the TMF and produces reports, as needed
• Manage study trackers and provide metrics as needed.
• Assists with the preparation and distribution of meeting agendas and minutes; actively participates in team meetings
• May act as a central contact for the study team for designated project communications, correspondence, and associated documentation
• Performs administrative tasks to support team members with Clinical Trial execution, as needed
• May act as main point of contact for investigator-initiated trials using Leap investigational product
• Assists the project team with the planning, preparation, and on-site support of investigators and other meetings
• Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections.
• Prepare and maintain assigned program files.

Education / Experience / Skills:

• Bachelor’s degree (advanced degree preferred)
• Minimum of 2 years of Clinical Trial experience (biotech preferred)
• Experience with oncology studies preferred.
• Global trial experience and ability to support more than one Clinical Trial
• Working knowledge of FDA regulations and ICH GCP guidelines.
• Experience with various Clinical Trial systems (EDC, CTMS, TMFs) trial master file organization, regulatory documents required
• Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
• Strong interpersonal and communication skills (verbal and written)
• Good organizational and time management skills.
• Willing to travel (up to 20%)