Senior Director, Quality Assurance
Company: Leap Therapeutics
Location: Cambridge
Posted on: August 7, 2022
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Job Description:
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 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.
Overview:
The successful candidate will be responsible for the leading the QA
department and strategy at Leap including the maintenance and
expansion of the Leap GxP quality systems and inspectional
readiness activities. This includes business elements covering
current Good Manufacturing Practice (cGMP), Good Clinical Practice
(GCP) and Good Laboratory Practice (GLP). Senior Director will
collaborate with a cross functional team provide oversight to
external vendors to ensure best GxP practices are implemented and
followed at internally Leap at contract service providers including
manufacturing organizations, testing laboratories, clinical
research organizations.
Responsibilities:
Qualifications:
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.
Keywords: Leap Therapeutics, Cambridge , Senior Director, Quality Assurance, Executive , Cambridge, Massachusetts
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