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SENIOR MEDICAL DIRECTOR, RESPIRATORY

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 Bio is seeking an experienced Senior Medical Director to support our Respiratory programs. Reporting to the SVP for Clinical Research, this is a crucial position at Vir. You will play a key role at all stages of development, focusing initially on the early stage development program through global product registration for influenza, COVID, and other respiratory infections.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

    • Lead the clinical development subteam responsible for all scientific aspects of conceptualizing and planning clinical trials and ensuring cross-functional integration, co-ordination and alignment to enable effective and efficient formulation of clinical development plans, study designs, and clinical study protocols
    • Represent clinical research in relevant sub-teams (eg, study management team, program team)
    • Manage, develop and oversee a team of direct reports within Clinical Research to support relevant development programs
    • Work collaboratively with regulatory and other functions to deliver the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, and investigator brochures
    • Provide oversight to ongoing medical monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management and drug safety surveillance
    • Ensure adherence to regulatory requirements of study conduct and industry standards of ICH/GCP and internal SOPs
    • Coordinate the collection and assimilation of ongoing data for internal analysis and review.
    • Oversee team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections, as applicable
    • Defending the clinical development program before regulatory authorities



QUALIFICATIONS AND EXPERIENCE

    • 6 + years' experience required in pharmaceutical industry with a proven success record in clinical research studies and trial design
    • Familiarity with infectious diseases and/or pulmonary or immunology medicine preferred
    • Experience in conducting global clinical trial programs
    • Basic understanding of ICH/GCP guidelines, FDA and EMEA regulations
    • Direct experience in the strategic and tactical implementation of drug development
    • Ability to think analytically and strategically to formulate, develop, and execute clinical plans
    • Strong leadership skills with an ability to set vision, lead change, and manage/mentor others
    • Excellent scientific written and oral communication skills
    • Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
    • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
    • Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
    • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings
    • Experience working with external partners (Pharma and/or government) a plus



EDUCATION

    • MD (or non-US equivalent of M.D. degree) or with sub-specialization in Internal Medicine/Infectious Diseases, or Pulmonary or related fields preferred; PharmD candidates with extensive clinical research and drug development experience may be considered



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.

SENIOR MEDICAL DIRECTOR, RESPIRATORY

San Francisco, CA
Full Time

Published on 11/16/2021

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