Manager, Clinical Operations (Temporary) at Vir Biotechnology

San Francisco, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Bachelor’s degree
6+ years of industry experience
Experience in managing late stage (Phase 2/3) clinical trials
Experience in CRO and vendor management
Experience in leading cross-functional team meetings
Ability 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
Experience with regulatory compliance audits and inspections
Experience directing and leading in a complex team environment
Previous experience as a CTM (preferred)

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 internal study management teams by developing agendas, drafting meeting minutes, organizing meetings
Develop study plans and relevant study documentation
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

Skills

Clinical Trial Management

Vendor Management

Sponsor Oversight

eTMF Management

Study Execution

ICH/GCP

Stakeholder Management

Study Planning

Cross-functional Team Leadership

Vir Biotechnology

Develops monoclonal antibodies for infectious diseases

About Vir Biotechnology

Vir Biotechnology develops treatments that leverage the immune system to combat infectious diseases. The company uses a proprietary monoclonal antibody platform combined with machine learning to create a database of human antibodies, which aids in developing effective medicines. Their pipeline includes candidates for hepatitis B, hepatitis delta, HIV, and various viruses like influenza and COVID-19. Vir stands out by collaborating with industry leaders and organizations to accelerate scientific advancements, with the goal of transforming lives through innovative therapies.

San Francisco, CaliforniaHeadquarters

2016Year Founded

$640.6MTotal Funding

IPOCompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Comprehensive healthcare coverage

Employer matched 401(k)

Employee stock purchase plan

Childcare assistance

Tuition reimbursement

Risks

Leadership instability due to key executive resignations may disrupt operations.

Job cuts and facility closures indicate potential financial strain.

Struggles to diversify beyond COVID-19 antibody success may impact revenue growth.

Differentiation

Vir Biotechnology uses AI-enhanced capabilities for monoclonal antibody development.

The company focuses on immune system manipulation for targeted therapies.

Vir's pipeline includes a potential functional cure for chronic hepatitis B.

Upsides

Increased interest in AI-driven drug discovery benefits Vir's AI capabilities.

The rise of personalized medicine aligns with Vir's monoclonal antibody focus.

Global pandemic preparedness funding supports Vir's broad-spectrum antiviral therapies.

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