Please note that this role is hybrid and based in Cambridge, MA. It requires a weekly onsite in office schedule. Full time remote work will not be considered.

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 Associate Director, Clinical Development Operations will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Leap SOPs. This role will work closely and collaboratively with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory and program management staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget. Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company.

Specific Responsibilities Include:

• Lead the management and execution of all clinical trials with a clinical program. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met (depending on the program scope, the Associate Director may still have direct trial management responsibilities)
• Provide strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed
• Develop and maintain budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals
• Collaborate with the appropriate functions in defining the outsourcing strategy for the development programs
• Establish the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.)
• Assist in the authoring of key regulatory documents (e.g., CTD, pre-meeting materials and briefing packages), study protocols, investigator’s brochures, annual IND progress reports, study postings, and CSR for consistency across programs
• Develop in-depth knowledge of the clinical data and assures appropriate transfer of that knowledge to cross-functional study teams to achieve operational excellence
• Provide input in cases of project prioritization exercises within the portfolio
• Ensure that study objectives are in line with the clinical development strategy and the overall corporate goals
• Ensure that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation
• Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines
• Collaborate with KOLs for feedback on study protocols and development plans

Education / Experience / Skills:

• Requires a Bachelor’s degree in Life Sciences or Pharmacy (advanced degree preferred) with 8 years of strong hands-on experience leading clinical trials execution, both in the USA and Europe
• Experience in supervisory role managing clinical operations staff
• Ability to take a leadership role, motivate staff, and drive high quality execution
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Effective communication and interpersonal skills; effective interaction with senior management.
• Solid well-grounded experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas
• Extensive experience managing CROs with outsourced key study functions/activities
• Ability to accurately project budgets and manage them across studies and projects
• Proficient in use of electronic clinical database software and other programs such as Microsoft Office, Smartsheet, etc
• Flexibility to travel domestically and internationally as required
• Onsite, Hybrid work schedule in Cambridge, MA

Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.