Associate Director, Clinical Operations

Vir-Biotechnology; San Francisco (CA); Hybrid; USD 177,000 - 247,000; Full time

Benefits offered by this job

Health and welfare benefit plans

401K match

Lunch in the office

Commuter benefits

Job summary

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company seeking an Associate Director, Clinical Operations, to independently lead global and complex oncology trials.

You will manage the Study Management Team, oversee CROs and vendors, and ensure successful execution from start-up to closeout. The role is based at our San Francisco headquarters with an expectation of at least 3 days per week in office, and involves leadership of cross-functional teams and strategic regulatory

Qualifications

• Bachelor of Science degree is required, preferably in the life sciences.
• 10+ years of clinical development experience in the biotech/pharmaceutical industry.
• Extensive experience working on oncology clinical studies.
• Experience in leading all stages of clinical trials including start up, maintenance and closeout.
• Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines.
• Experience with regulatory compliance audits and inspections.
• Experience directing and leading in a complex team environment.
• Ability to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when needed.
• Flexibility to travel domestically and internationally.

Responsibilities

• Provide strategic input and leadership in study setup and execution of highly complex oncology clinical trials. May support multiple trials
• Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate
• Develop and manage study contracts, budgets and timelines
• Author/review core study documents including protocol and Informed Consent Forms
• 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
• Able to support regulatory strategy and assess trial/program impact and RFIs from multiple countries
• May lead RFP process, budget development, and study forecast/planning including timelines
• May perform sponsor oversight site visits
• Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Reviews monitoring trip reports and track resolution of all action items
• Manage team with direct reports within therapeutic area
• Clinical Operations lead on cross functional project teams and alliance teams

Skills

Study management

Vendor management

Regulatory affairs

Cross-functional leadership

Budget management

Education

Bachelor of Science in Life Sciences

Job description

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN ® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease. PRO-XTEN ® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

Vir Bio is looking for an Associate Director, Clinical Operations, responsible for independently leading global and complex clinical trials. You will lead the Study Management Team, oversee clinical vendors and CRO(s) and is accountable for ensuring the successful execution and conduct of clinical trial(s). In this role, you will be directly managing a large complex early phase oncology study. Activities will include vendor selection and management, protocol and study document development, feasibility/study start-up, maintenance, and closure. You will serve in a leadership role within Clinical Operations and may lead/participate on SOP development working groups and initiatives, manage direct reports, and provide stakeholder management for cross functional teams within clinical development.

This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.

WHAT YOU'LL DO

• Provide strategic input and leadership in study set-up and execution of highly complex oncology clinical trials. May support multiple trials
• Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate
• Develop and manage study contracts, budgets and timelines
• Author/review core study documents including protocol and Informed Consent Forms
• 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
• Able to support regulatory strategy and assess trial/program impact and RFIs from multiple countries
• May lead RFP process, budget development, and study forecast/planning including timelines
• May perform sponsor oversight site visits
• Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Reviews monitoring trip reports and track resolution of all action items
• Manage team with direct reports within therapeutic area
• Clinical Operations lead on cross functional project teams and alliance teams

WHO YOU ARE AND WHAT YOU BRING

• Bachelor of Science degree is required, preferably in the life sciences
• 10+ years of clinical development experience in the biotech/pharmaceutical industry
• Extensive experience working on oncology clinical studies
• Experience in managing and leading clinical studies both in early phase through late stage of development
• Experience in leading all stages of clinical trials including start up, maintenance and closeout
• 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
• Ability to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when needed
• Flexibility to travel domestically and internationally

WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $176,500 to $246,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

For hires based in the United States, Vir Biotechnology, participates in E-Verify .