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 (AD)/Director (D) of Clinical Program Management, reporting to the VP, Business and Operations Strategy, will ensure tight integration and transparency of all clinical development functions. He/She will be responsible for maintaining detailed program plans, inclusive of timelines, ensuring all efforts are streamlined and being managed on time and on budget. The AD/D of Clinical Program Management will be part of an enterprise-wide Program Management team and responsible for seamless communication and integration across all of Leap’s business functions.
Specific responsibilities include:
Oversee phase-appropriate program management for clinical stage programs by identifying critical development objectives and partnering with project and functional leaders to ensure assets move through activities and phases of development on time and on budget.
- Lead cross-functional teams comprised of members from diverse subject areas – including, but not limited to – clinical operations, medical, regulatory affairs, biometrics, safety, quality, and supply – to facilitate transparent communication and knowledge sharing. Serves as conduit, coordinating and integrating timelines between other Leap departments including Finance, CMC and Translational Science.
- Effectively manage team meetings, including the Program Core Team (PCT), by ensuring that objectives are clearly defined, capturing, and disseminating meeting outcomes, information, and action items, and following up on critical actions with teams
- Drive strategic alignment and seamless execution across all key development functions.
- Innovate and maintain tracking systems and metrics, translating complex data into actionable insights for project and program advancement.
- Proactively identify, track, communicate, and propose resolution options for discrepancies in priorities and plans, prioritize complex and multiple/conflicting responsibilities and/or issues.
- Champion strategies to anticipate and mitigate risks to project timelines and budgets, ensuring programs run efficiently.
- Communicate program status to company stakeholders, including senior management.
- Craft compelling and insightful presentations for board meetings, investors, and key stakeholders, showcasing the progress and potential of development programs.
- Contribute to a positive team environment that fosters trust, robust debate and ensures clear transparent communications.
- Design and build the Program Management function to enable the company’s growth while taking a hands-on approach to content creation and strategy execution.
Education / Experience / Skills:
Requires minimum of 10 years of pharmaceutical, biotech industry programs, or program management experience and strong knowledge of cross-functional drug development, including global regulatory authority guidelines.
- Master’s degree or equivalent (scientific or healthcare discipline) preferred.
- Oncology experience preferred.
- Ability to lead and manage a matrixed Program team and coordinate cross-functional aspects of drug development (e.g., medical, regulatory, clin ops, safety, biometrics, quality, supply, etc.) to achieve development milestones.
- Ability to create a comprehensive Program plan and prioritize the execution of complex tasks within a team environment.
- Effective communicator who can develop strong relationships to facilitate Program operations outside the context of formal meetings; able to effectively communicate with supervisor, co-workers, and external partners daily, in-person, by phone, and by email.
- Ability to influence teams to meet or exceed Program deadlines consistently.
- Experience in leading and managing team meetings; proven ability to create opportunities for meeting efficiency.
- Enthusiastic about creating a thriving environment for teamwork, collaboration, and cooperation.
- Proactive problem solver with detailed organizational skills
- Working knowledge of Microsoft Office Suite and program management software, including MS Project, SmartSheet, etc.
- Ability to inspire, motivate, and effectively lead diverse groups and teams.
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.