Vir Bio is seeking an Associate Director, Clinical Operations, responsible for leading departmental activities, compound/therapeutic area leadership, study set up and execution, as well as all vendor management and sponsor oversight activities. Activities will include vendor selection and management, protocol and study documents development, study start-up, maintenance, and closure. Candidate will serve in a leadership role with Clinical Operations managing direct reports, stakeholder management for cross functional teams, as well as partner/alliance management within clinical development. This position will report to the Head of Clinical Operations.
RFP process, budget development, and study forecast/planning including timelines.
Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables.
Develop study plans and relevant study document templates for study teams.
Strategic input and leadership in study set-up and execution.
Manage team with direct reports within therapeutic area.
Clinical Operations lead on cross functional project teams and alliance teams.
Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies.
QUALIFICATIONS AND EXPERIENCE:
8+ years of clinical development experience in the biotech/pharmaceutical industry.
Experience in managing clinical studies in all phases.
Ability to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when needed.
Ability to manage multiple priorities.
Experience with compound lifecycle from IND to NDA.
Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes including and not limited to data management, biostatistics, medical monitoring, drug safety, regulatory affairs.
Experience with regulatory compliance audits and inspections.
Experience directing and leading in a complex team environment.
EDUCATION AND EXPERIENCE:
Bachelor’s or advance degree in a scientific or healthcare discipline preferred, and relevant experiences in industry.