The Clinical Research Oncology group at Vir Biotechnology, Inc. develops and executes early development clinical strategies with a mission to deliver medically-differentiated therapies that provide meaningful improvement to patients. The Director in Clinical Research Oncology role provides an exciting opportunity to participate in the growth and expansion of the group. Working in collaboration with the broader Clinical Research Oncology team, the Director in Clinical Research Oncology leads several aspects of new and ongoing clinical study-related activities. These activities encompass,  leading functional area activities during program implementation, clinical study startup, execution, data analysis, regulatory submissions, data reporting, and study close out.

This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.

WHAT YOU'LL DO

• Be the clinical study lead for one or more studies and is responsible for implementation and execution of assigned clinical study activities
• Represent Clinical Research Oncology on sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary contact for questions and inquiries to Clinical Research Oncology regarding studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting
• Provide scientific and clinical leadership to study team(s)
• Provide clinical science expertise at study team meetings in and collaborate with study team members
• Support clinical development planning (in collaboration with the Program Executive and Medical Monitor to support future planning)
• Maintain an understanding of assigned protocols and protocol requirements
• Plan and lead the implementation all study startup/conduct/close-out clinical science activities as applicable, and in collaboration with Clinical Operations
• In collaboration evaluate innovative study designs
• Lead protocol and informed consent form (ICF) development process with; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
• Lead site-facing activities such as training and serving as primary contact for clinical questions, triage with medical monitor as needed
• Manage activities related to data generation and validation, including case report form (CRF) design, clinical data review/query resolution; ensure consistent, quality data review
• Develop data review plan (in collaboration with Data Management), conduct clinical data trend identification; provide trends and escalate questions to Medical Monitor
• Develop clinical narrative plan; review clinical narratives
• Review development of site and clinical research associate (CRA) training materials and presentation at site initiation visits (SIV) and Investigator meetings and support on study committees (e.g., safety assessment committee) activities
• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of regulatory documents (e.g., IB, DSUR, regulatory responses)
• Collaborate and serve as primary liaison between external partners for scientific advice
• Mentor junior clinical scientists as needed

WHO YOU ARE AND WHAT YOU BRING

• PhD, PharmD or equivalent
• At least 10+ years of experience in oncology clinical research (in an academic, pharmaceutical company, or CRO environment) related to the design and/or conduct of clinical studies is required
• Proficiency in GCP/ICH, drug development process, study design, statistics, clinical operations
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of the establishment and operation of data monitoring committees, safety review committee, and independent date monitoring committees
• Results driven and able to achieve creative and sound outcomes
• Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
• Ability to make sound and timely decisions; agile in learning and action oriented