Director, Clinical Operations
AlmaSalary not specified
Full Time
Mid-level (3 to 4 years)
Manager, Clinical Operations (Temporary) at Vir Biotechnology
San Francisco, California, United States
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the expected compensation for this position?
The expected hourly range for this position is mentioned but not fully specified in the job description.
Is this role remote or does it require office presence?
This position is located in the San Francisco headquarters with an expectation of 3 days per week in office.
What experience and skills are required for this role?
Candidates need a Bachelor’s degree with 6+ years of industry experience, experience managing Phase 2/3 clinical trials, CRO and vendor management, leading cross-functional teams, and understanding of FDA, EMEA, ICH, and GCP guidelines.
What is the company culture like at Vir Biotechnology?
Vir Biotechnology is committed to creating a company where everyone feels supported and encouraged to give their best, believing that the success of colleagues drives the success of the mission.
What makes a strong candidate for this Manager, Clinical Operations role?
Strong candidates have previous experience as a CTM, study closeout experience, ability to manage multiple trials, experience with compound lifecycle from IND to NDA, and regulatory compliance audits.
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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