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. 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.
About the Position
The Associate Director/Director, Clinical QA is responsible for compliance with GCP regulations, providing strategic input to GCP-related compliance activities, managing audits of clinical vendors, providing leadership, and quality oversight of Shattuck Labs sponsored clinical trials. This position may provide backup for GMP and GLP-related compliance activities. This position reports directly to the Head of Quality. The title will be commensurate with experience.
Summary of Key Responsibilities
- Develop and deliver robust procedures and processes for efficient quality oversight of clinical trials.
- Manage vendor oversight of clinical quality activities including but not limited to maintaining vendor compliance, audit scheduling, report writing, risk notification to teams and management, and vendor quality agreements.
- Review, provide input and/or approve essential clinical documents including but not limited to study protocols, informed consents, investigator brochures, pharmacy manuals and clinical study reports.
- Develop and execute clinical Quality Management Plans for all clinical trials.
- Maintain knowledge of current (international) regulatory requirements and collaborate across the clinical organization to ensure compliance.
- Ensure inspection readiness of Shattuck Labs and clinical trial vendors.
- Provide routine updates to senior management, including escalation of issues.
- In collaboration with the quality teams at clinical vendors, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and adequately address root cause.
- Create an environment of quality culture by setting an example and leading or facilitating training for clinical quality topics.
- Counsel project team members and/or management on appropriate corrective and preventive actions to audit findings, policies and procedures, technical problem solving, and work methods.
- Participate in hosting audits and regulatory inspections in accordance with Company policies and procedures.
Required Qualifications and Skills
- Degree (advanced degree preferred) in relevant field (science, engineering, public health)
- At least 7 years’ experience in GCP Quality or equivalent position, ideally with biological products.
- Thorough knowledge of and experience implementing GCP regulations.
- Prior direct involvement in multiple clinical regulatory inspections.
- Experience in managing training programs.
- Proven ability to review and evaluate the content of various documents, including but not limited to standard clinical trial documentation, all documentation within a quality management system, standard operating procedures, and policies.
- Proven ability to collaborate with other functional areas within the company.
- Proficient in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
- Able to multi-task productively, applying time management processes and procedures effectively for on time delivery.
- Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem, and working with others to correct problems.
- Works toward common goals by supporting, encouraging, and sharing information with colleagues.
- Speaks, writes, listens, and presents information in a logical and articulate manner.
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.