THE OPPORTUNITY:
Supporting the development portfolio, the Associate Director, Biosample Operations will plan all project management and operational activities required to operationalize the VIR biomarker strategies (PK, ADA, PD, Exploratory Biomarker and CDx) for programs across the VIR portfolio. You will ensure continuity and integrity across projects, coordinate assay development and implementation activities and act as the primary contact for projects requiring biomarker and diagnostic activities including collection, delivery and assay testing of all biosamples within one or more clinical projects or clinical studies. You will also be responsible for any biomarker and CDx sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables. In addition to the core biomarker activities, you will be involved in some clinical operation activities for clinical site management in the context of biomarker sample collection education and compliance at clinical sites.
This role will report to the VP, Clinical Operations Oncology.
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO:
- Drive the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas.
- Accountable for project management and appropriate planning of related biomarker analysis and samples management costs within a project(s) or clinical studies.
- Plan and implement the PK and biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development, kit development, database set up, etc.
- Ensure the timely and efficient delivery of all biosamples, including scheduling analyses with relevant vendors, sample processing and shipment, analysis, data delivery and final sample disposition.
- Serve as vendor operations lead with central lab and other ancillary labs and oversee sample shipment and coordination of sample analyses, data transfers and sample reconciliation.
- Be the first contact for PK biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinate with internal and external partners.
- Provide guidance during protocol, informed consent form and CRF development to ensure feasibility of biological sampling and alignment with ICH/GCP, sample testing plans and data collection and reconciliation.
- Develop and implement a global strategy for standardization of clinical sample management for inspection readiness including development of SOPs for practices across clinical programs.
- Accountable for training, managing, and providing oversight of Biomarker Operations team and driving the overall biomarker operational strategy for the pipeline.
WHO YOU ARE AND WHAT YOU BRING:
- Life Science Degree or Higher with at least 7+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
- 3+ years Clinical or biological laboratory experience with involvement in the processing or analysis of biological samples.
- Clinical development experience working on a cross-functional team responsible for the execution of clinical studies, oncology preferred.
- Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance).
- Project management skills and knowledge of project management tools.
WHO WE ARE AND WHAT WE OFFER:
The expected salary range for this position is $168,500 to $246,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch each day in the office.
#J-18808-Ljbffr