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 in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap has a strong financial position and in September 2021 closed a public offering with gross proceeds to Leap of approximately $104 million. Leap is based in Cambridge, MA. For more information about Leap Therapeutics, visit http://www.leaptx.com.
• Play a key role in the project management and integration of cross functional CMC activities to support clinical and commercial development of monoclonal antibody therapies.
• Collaborate with various internal and external functions including upstream and downstream manufacturing, quality control, quality assurance, regulatory, and supply chain to ensure that plans and schedules support business priorities.
Specific Responsibilities Include:
• Working directly with the individual functional areas, develop and maintain project schedules for CMC operations including process development, manufacturing, quality, and supply chain
• Assist the functional area leaders with driving decision making for the project and track all decisions
• Support preparation and management of CMC program budget(s)
• Manage and track vendor invoices and reconcile against the CMC budget
• Manage vendor spending against proposals including all accrued and cancellable cost estimates
• Maintain agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.
• Assist with identifying and defining risks, mitigations, and/or contingency plans.
• Execute scenario planning and provide options for teams
• Ensure project progress and upcoming deliverables are understood by the CMC team and ensure that action items are tracked to completion
• Support management of strategic external relationships by aligning internal and external requirements/resources to achieve timelines, milestones, and deliverables.
• Assist with the creation and update of near- and long-term project plans with clearly defined goals
• Report program status into governance meetings
Education / Experience / Skills:
• Minimum of B.S. in biology, bioengineering, biochemistry, or equivalent
• Minimum of 5-10 years’ experience; preferably hands-on in a relevant CMC area of biologics (for example, cell culture, purification, or fill/finish) followed by strong project management experience
• Advanced understanding of project management tools. Hands-on, roll-up-your-sleeves independent approach, with high sense of urgency and drive for results
• Highly motivated and able to deliver in a predominantly remote work environment
• Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop good working relationships with cross functional personnel at all levels
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.