Associate Director, Clinical Operations

Vir Biotechnology

Posted on: May 12, 2022

Closing: June 11, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Biotechnology 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 within Clinical Operations managing direct reports, stakeholder management for cross functional teams, as well as partner/alliance management within clinical development.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

    • Lead overall operation of the entire clinical study/program including project planning, budget, resource management and contract research organization management.
    • Handle clinical operational plans and incorporate the study and scientific plan.
    • Develop study related documents and overall direction for the clinical sites to establish protocol development.
    • Ensure compliance with good clinical practices, good manufacturing practices and regulatory guidelines.
    • Recommend and implements innovative process ideas to impact clinical trials management.
    • Develop and run clinical budget and develop contingency plans for clinical trials.
    • Coordinate clinical trials staff and run all aspects of clinical operational plan.
    • Responsible for running full scope of study, protocol and scientific publications. Acts as a cross functional liaison to ensure study plan aligns with business development strategies. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
    • Serves as Clinical Operations representative at cross-functional team/sub-team meetings.

QUALIFICATIONS AND EXPERIENCE

    • Bachelor’s or advance degree in a scientific or healthcare discipline preferred, and relevant experiences in industry
    • 10+ years of clinical development experience in the biotech/pharmaceutical industry
    • Experience with compound lifecycle from IND to NDA/BLA
    • Detailed 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 managing Contract Research Organizations(CROs) for fully outsourced trials
    • Experience with regulatory compliance audits and inspections
    • Experience directing and leading in a complex team environment
    • Experience in leading 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
    • Experience as a Clinical Monitor (CRA) or Site Coordinator (CRC) preferred
#LI-Remote
This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US.  If you move forward in the hiring process, VIR recruiters will discuss options with you.
Vir’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 benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer.  We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

Vir Biotechnology

Posted on: May 12, 2022

Closing: June 11, 2022

Salary($): Undisclosed

Position Type: Full Time

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