Shattuck Labs, Inc. (www.shattucklabs.com) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. Shattuck has created over 300 unique bi-functional fusion protein therapeutic candidates. The company’s lead wholly owned program, SL-172154 (SIRPα-Fc-CD40L), which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in a Phase 1 trial. A second compound, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in collaboration with Takeda Pharmaceuticals. Additionally, the company is advancing a proprietary Gamma Delta T Cell Engager, GADLEN™, platform, which is designed to bridge gamma delta T cells to tumor antigens for the treatment of patients with cancer. Shattuck has offices in both Austin, Texas and Durham, North Carolina.
The translational medicine department at Shattuck is responsible for designing and implementing a translational research plan for each of the clinical stage assets. This includes designing and implementing biomarker assays into clinical studies, interpreting biomarker data and developing companion diagnostic (cDx) assays.
We are seeking a highly motivated scientist to manage human biological samples collected in our clinical programs. These samples are collected for patient screening, biomarker, and translational research and for potential application in a companion diagnostic assay. You will be responsible for all day-to-day vendor, sample, and study level management and oversight across all clinical programs for all biomarker and translational medicine efforts.
The BioSample Manager will be responsible for tracking the entire sample lifecycle from sites to the vendors including managing sample inventories and distribution of samples for biomarker analysis. In addition, they will contribute to the development of human biosample-related components of clinical trial documents. The position requires working in close partnership with the Clinical and Translational Sciences teams, Biometrics, and in some instances with the Pre-clinical, Non-clinical and Regulatory teams. The position also requires working extensively with external vendors and clinical site teams.
Summary of Key Responsibilities
· Work closely with the Director of Translational Medicine and other functional areas to define and implement the translational science objectives for clinical phase assets.
· Manage tracking, logistics and quality operations for biological specimens supporting clinical trials from collection to analysis by working collaboratively with clinical teams, sites, central lab vendor, and specialty lab partners
· Attend all study level operations meeting and act as the liaison between clinical operations and biomarkers/translational medicine for all ongoing clinical trials. Communicate with management and clinical trial teams to ensure transparency of the condition and completeness of clinical sample collection and movement throughout the course of the trials.
· Maintain detailed biosample inventory that is accurate, complete, and up-to-date
· Responsible for sample lifecycle management documenting chain of custody from sample receipt through to exhaustion/return/destruction
· Oversee and manage labs and vendors supporting human biological sample efforts
· Responsible for accurate collection of samples to support clinical and diagnostic regulatory submissions. Develop site training materials and provide sample collection training to clinical site staff during SIVs and in the event of deviations.
· Develop elements of the clinical trial protocol, ICF and study procedures manual/lab manuals relevant to specimen collection and intended use, and assist in patient consent verification
· Work effectively with internal colleagues to fulfill sample (e.g. tumor, blood, derivatives, etc.) shipment requests for external analyses such as flow cytometry, protein assays (e.g. western blots, and IHC), gene expression assays, NGS, etc.
· Participate in sample management process improvement projects
· Follow GCP/GLP/ICH guidelines, global legal and regulatory standards for human biological sample management, and internal standard operating procedures (SOPs)
· Assist in development of SOPs for human biological sample management
· Must have either a MS in a biological sciences or clinical discipline with at least 2 years of experience in managing a human biorepository in the pharmaceutical or life sciences discipline; or a BS in a biological science or clinical discipline with at least 5 years or more years of equivalent working experience
· The successful candidate should have a minimum of 2 years of experience in clinical drug development or clinical trial execution with exposure to biomarkers, pharmacokinetics or immunogenicity sample activities including sample collection procedures and logistics considerations
· Direct experience in the configuration and management of a LIMS is required
· Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems and controlled sample management systems
· Have a genuine interest in understanding the science and supporting the clinical development of the Shattuck pipeline.
· Be a team player, with excellent interpersonal skills and a strong work ethic, who is willing to work collaboratively and learn from a multifunctional team.
· Be proactive in anticipating and addressing issues. Precise record keeping skills with attention to detail are essential as well as the ability to track and resolve issues
· Excellent communication (verbal and written) and interpersonal skills
· Self-motivated and able to prioritize and manage multiple projects simultaneously. Have outstanding organizational skills and operational capabilities. Ability to handle complex issues and multi-task current project demands; must be able to prioritize and deliver effectively with minimal supervision.
· Have enthusiasm, scientific curiosity, high emotional intelligence, sound temperament and professional attitude.
Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.