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
The Sr. Manager/Associate Director, Clinical Supply is responsible for operational oversight of the planning, packaging, labeling and distribution of Clinical Trial Materials (CTM) and any additional study products to support clinical trials. He/she is responsible for oversight and management of clinical supply distribution and associated external vendors. He/she ensures operations and activities are executed in accordance with all internal Standard Operating Procedures (SOPs) and in accordance with all county, state, and federal regulations including Good Manufacturing Practice (GMP) regulations and ICH guidelines.
Specific Responsibilities Include:
• Works cross-functionally with internal departments and external resources on clinical supply planning and execution in support of Leap’s clinical development programs
• Manages outsourced label and packaging and clinical supply chain logistics
• Partners with Clinical Development Operations to identify demand assumptions, including enrollment rate, number of sites, number of countries, etc.
• Recommends packaging requirements based on an understanding of the technical aspects of the packaging to provide patient friendly packages that support site dispensing approaches
• Designs packaging, labeling, and subsequent assembly plans for CTM, comparators and ancillary supplies
• Participates in development, testing and management of IRT systems as related to clinical supply
• Ensures appropriate lead times are planned for the ordering and packaging of clinical trial supplies by monitoring recruitment rates and actual supply needs; ensures continuous re-assessment of supply needs as recruitment and the study progresses by monitoring the use of adequately dated clinical trial supplies at each investigational site
• Manages and directs clinical trial supplies return process of vendor by ensuring the reconciliation of CTM and documentation of destruction.
• Participates in clinical study team meetings; advises the study team on the optimal supply strategy, aligns with study details and collaborates in achieving study objectives by providing supporting information to the study teams as required; communicates and discusses clinical trial supply timelines, cost and risk limitations
• Manages the storage, distribution and inventory tracking of CTM and ancillary inventory throughout the clinical supply chain in compliance with GMP requirements.
• Schedules and implements labeling, packaging and quality release operations with CMOs and internally with CMC and Quality departments to ensure continuous clinical supply
• Working with Quality department, Coordinates GMP auditing activities at external vendors; provides management with accurate time frames for resolution of delays in obtaining supplies for clinical projects; recommends insight and ideas into procedural improvements as needed and assist in the implementation of the improvements
• Creates label design and coordinates approvals, including obtaining language translations for all participating countries and the associated Health Authority regulatory requirements; obtains cross functional approvals on the labels within country representatives as required.
Education / Experience / Skills:
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
- Hands-on experience supporting and understanding GMP, Good Clinical Practice (GCP), and ICH guidelines as related to CTM labeling, packaging and distribution operations and the overall drug development process
- Hands-on experience supporting clinical supply chain for clinical trials
- Proficiency with Microsoft Office (including MS Project)
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
- Bachelor’s degree and a minimum of 6 years relevant clinical drug supplies experience in a pharmaceutical, biotechnology, contract research organization (CRO)
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.