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 successful candidate will support existing and new clinical programs as a key member of the QA organization. S/he will collaborate with and provide guidance to cross functional teams to maintain and optimize a phase appropriate quality system for the conduct of clinical studies and oversight of CROs. Responsibilities include management and optimization of GCP and GVP quality systems, internal training, trending and reporting on deviations and corrective actions, proactive risk management and manage/conduct audits.
The role is within a highly motivated team and provides opportunities to cross train and enhance skills in the GxP areas. The successful candidate will be a key contributor to the departmental objectives and support the management of key corporate milestones.
Responsibilities
- Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams.
- Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for clinical development.
- Develop audit management plans and audit strategy for ongoing clinical trials.
- Coordinate and/or conduct external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
- Develop standards to support clinical project teams and oversee a network of vendors providing regulated services.
- Participate in the development of cross-departmental standard operating procedures, work instructions, forms, and templates.
- Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP).
- Collaborates with business functions to leverage data (e.g. data management and risk-based study management) to manage risks across clinical studies.
- In depth knowledge of ICH GCP E6 R2, and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.).
- In depth knowledge of the principles of GxP practices and applicable regulations guiding the drug development life cycle.
- Act as a quality leader to promote cross-functional collaboration to proactively identify and mitigate risks.
Education/ Experience/ Skills
- BS / MS in a scientific or health-related field.
- Minimum of 8+ years of compliance experience in quality functions in pharmaceutical/biotech industry.
- Preference given to candidates demonstrating GCP experience.
- Experience with GLP quality considered a plus.
- Experience with biologics, preferably with monoclonal antibodies.
- Experience with managing GCP compliance at clinical sites.
- Advanced understanding of the application of GCPs to early development and commercial products, FDA regulations and ICH guidelines.
- Hands-on leader, able to provide solution minded approach and flexibility to emerging challenges.
- 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.