Manager, Clinical Operations (Temporary) jobs in United States
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Vir Biotechnology, Inc. · 2 months ago

Manager, Clinical Operations (Temporary)

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives. They are seeking a Manager, Clinical Operations (Temporary) to lead and support multiple Phase 1-3 clinical trials, including vendor management and study execution.

BiotechnologyHealth CareMedicalTherapeutics
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Comp. & Benefits
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Responsibilities

Provide strategic input and leadership in study execution of clinical trials
Support ongoing clinical trials and may lead cross functional study teams
Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables
Support the internal study management teams by developing agendas, drafting meeting minutes, organizing meetings
Develop study plans and relevant study documentation
May serve as the main point of contact for day-to-day operational activities; lead cross-functional team meetings
Act as cross functional resource/SME on ICH/GCP issues; facilitate inspection ready status of clinical trials
Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies
Oversee TMF to ensure clinical trial documents are filed according to the TMF management plan
Support department level initiatives and deliverables

Qualification

Clinical trial managementCRO managementRegulatory complianceVendor managementStudy documentationCross-functional leadershipStakeholder managementMeeting organizationTeam collaboration

Required

Bachelor's degree with 6+ years of industry experience
Experience in managing late stage (Phase 2/3) clinical trials; study closeout experience preferred
Experience in CRO and vendor management
Experience in leading cross-functional team meetings
Able to successfully work across multiple active clinical trials at once
Experience with compound lifecycle from IND to NDA
Thorough understanding of FDA, EMEA, and ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes, including but not limited to, data management, biostatistics, medical monitoring, drug safety, and regulatory affairs
Experience with regulatory compliance audits and inspections
Experience directing and leading in a complex team environment

Preferred

Study closeout experience
Previous experience as a CTM

Company

Vir Biotechnology, Inc.

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At Vir Biotechnology, Inc., we leverage the immense potential of the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.

Funding

Current Stage
Public Company
Total Funding
$908.6M
Key Investors
Biomedical Advanced Research and Development Authority (BARDA)Bill & Melinda Gates FoundationGlaxoSmithKline
2023-10-03Grant· $50M
2023-05-02Grant· $10M
2022-10-04Grant· $55M

Leadership Team

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Marianne De Backer
Chief Executive Officer
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Louis Picker
Co-Founder
Company data provided by crunchbase