Sr. Manager/Associate Director, Clinical Supply
Company: Leap Therapeutics, Inc.
Location: Cambridge
Posted on: June 24, 2022
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Job Description:
Sr. Manager/Associate Director, Clinical SupplyCompany
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.comGeneral Responsibilities: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:
Keywords: Leap Therapeutics, Inc., Cambridge , Sr. Manager/Associate Director, Clinical Supply, Healthcare , Cambridge, Massachusetts
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