Silverback Therapeutics, a Seattle-based biotechnology company, is seeking a highly motivated Clinical Operations professional to join our growing Clinical Development Department. This person will be responsible for managing the day-to-day activities related to specimen collection for sponsored clinical trials and for central laboratory vendor management. This role will manage the lifecycle of biological samples from collection to final disposition. Responsibilities include daily sample tracking, timely query resolution and reconciliation to ensure a robust chain-of-custody.
These may include but are not limited to:
- Partner with the Clinical Study team and Translational Science to implement sample specimen collection strategy including but not limited to collection, shipment, storage and management of biologic specimens (e.g., PK, PD, Genomics, Biomarkers, etc.).
- Review clinical study protocols, informed consent documents and service provider laboratory scope of work documents to ensure accurate and consistent collection of samples.
- Collaborate with the Clinical Study team and Translational Science to ensure single internal point of contact regarding specimen tracking.
- Participate in the selection of central laboratory vendors, perform consistent oversight and provide timely input to ensure that the study is executed according to the agreed project plan, resolving and/or escalating issues accordingly.
- Partner with Data Management to implement strategy for specimen data collection and discrepancy management (e.g., Data Transfer Plan with analytical laboratories).
- Manage specimen sample tracking process and discrepancies as identified by Clinical Study staff or Translational Science. As needed, facilitate timely resolution of lab sample queries.
- Liaise with Clinical Study teams to ensure proper shipment of specimens and respond to issues as needed.
- Through diligent vendor oversight, maintain quality control, accurately curated sample inventory to ensure timely distribution of samples to analytical labs. Track consent as it relates to testing and analysis.
- Prepare study-specific training materials and participate in clinical site training.
- Write and/or review SOPs and related documents including, but not limited to, training, tools, templates, and manuals.
- Attend and participate in clinical team meetings, and interact in a positive, professional manner.
- Review status of samples received and completeness of data and create reports for study teams when requested.
- Contribute to process improvement projects important in building a first-in-class clinical operations group at Silverback Therapeutics.
- Bachelor’s degree (or equivalent) in a relevant scientific field.
- 5+ years of biotech/pharmaceutical clinical trial experience.
- Oncology and/or immuno-oncology program support experience strong desired.
- Successful history of managing vendor relationships and performance.
- Prior experience developing documentation and training materials for broad audiences.
- Technical knowledge to successfully maintain electronic files.
- Strong capabilities handling large data files used for tracking sample inventories and for data reconciliation across various databases.
- Knowledge of clinical laboratory assays and specimen handling.
- Phase 1-3 clinical study experience including biological sample management.
- Strong working knowledge of the international conference on harmonization (ICH), good clinical practice (GCP), and good laboratory practice (GLP) guidelines and other applicable regulatory guidelines required.
- Excellent communication skills, both oral and written.
- Strong organizational and time management skills.
- Excellent analytical and assessment skills.
- Excellent judgment and problem-solving skills.
- Demonstrated project and operational management experience (e.g., effectively managing relationships with key internal stakeholders as well as external collaborators).
- May require up to 10% domestic travel (little travel is anticipated during the COVID-19 pandemic).
- A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company leveraging our proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Our platform enables us to strategically pair linker-payloads that modulate key disease-modifying pathways with monoclonal antibodies directed to specific disease sites. Initially, we are creating a new class of targeted immuno-oncology agents that direct a myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. We are located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to email@example.com. We are an equal opportunity employer.