Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet's lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit www.sagimet.com.
Position Summary
Collaborate with the Clinical Development Team in clinical trial sample management including the strategy, planning, and vendor oversight of the processing, tracking, and reconciliation of biomarker, PD, PK, and other types of biological samples, collected for an assigned project.
The Sample Manager will be an integral member of the program team, responsible for the oversight of trial sample operations, managing end-to-end operational planning, including vendor set-up, logistical planning, and coordination, to ensure high-quality sample collection, processing, shipping, receiving, analysis and storage of clinical trial samples in accordance with protocol requirements, ICH GCP guidelines, regulatory requirements, third party lab/analysis vendor specifications, and Sagimet procedures.
Clinical Sample Management, Key Responsibilities
Accountable for the oversight and supervision of clinical trial sample management: planning, processing, tracking, coordination, reconciliation, and life-cycle management to maintain chain-of-custody in a GxP compliant setting.
Leads logistical execution of sample processing, shipping, and timelines associated with sample testing, transfer, and analysis for study deliverables in coordination with Clinical Operations/Biomarker Lead/Clinical Pharmacology Lead, clinical sites, external lab vendors, and couriers. Ensures process is appropriately managed from time of sample collection through delivery of results and long-term sample storage.
Develops and reviews lab manuals/requisition forms, lab specifications, kit builds, SOPs, sample labels and other controlled documents related to sample management.
Produces and disseminates sample status updates and tracking reports for internal and external use.
Ensure stakeholder alignment on clinical trial objectives.
Manages external clinical trial sample processing laboratories and vendors and effectively builds standard procedures with service providers to optimize execution.
Performs regular budget reconciliation with sample processing laboratories.
Supports data transfer specification/agreement drafting to align with the testing objectives, and management of final long-term storage or future use approval of clinical samples.
Informs leadership of any quality deviations for clinical sample testing. Actively collect, interpret, review, and document quality deviations for clinical sample handling or testing in the appropriate system.
Responsible for reviewing TMF filing documents that originate from lab vendors, in accordance with regulatory requirements.
Qualifications
Bachelor's Degree or international equivalent in life sciences with 4+ years of experience in the pharma industry managing sample logistics.
Experience establishing sample management oversight strategies and sample tracking systems for a large international program.
Sample Vendor Management Experience (PK/PD, tissue and imaging)
Experience managing Global International logistics (e.g. customs, import/export Licenses, insurance etc.) associated with sample shipments from clinical sites to central labs and to third party labs as required.
Solid understanding of GLP, GCP-ICH and/or GCLP guidelines, and knowledge of product development processes.
Successful experience in supporting globally operating multi-functional teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors).
Collaborative self-starter who can balance the needs of an agile company with the requirements of a structured clinical testing environment.
Proven ability to communicate and collaborate effectively within and across teams.
Experience interacting with external collaborators with the ability to build strong relationships.
Knowledge of risk management, project reporting, and project management tools.
Strong interpersonal skills.
Excellent organization, verbal, and written communication skills to facilitate operational excellence throughout study conduct.
Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
Compensation
The expected base salary range for this role is $132,000 - $165,000 Compensation will be based on a variety of factors, including experience, qualifications, and internal equity. Sagimet offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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