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 Clinical Research Director to support our respiratory program. Reporting to SVP of Clinical Research, this is a crucial position at Vir. You will play a key role at all stages of product development, focusing on the early-stage development program through global product registration for COVID, Influenza, and other respiratory infections.
- Responsible for scientific aspects of conceptualizing and planning clinical trials and ensuring cross-functional integration, co-ordination and alignment to enable effective and efficient formulation of development plans, study designs, and clinical study protocols
- Represent clinical research in relevant sub-teams (eg, study management team)
- 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 ongoing medical and data 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.
- Serve as part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections, as applicable
- Prepare scientific information for presentations to senior management, regulatory agencies, scientific conferences, clinical study investigator meetings, and scientific advisory boards
- Work collaboratively with other functions to develop publication strategies and develop manuscripts for publication in peer-reviewed journals
- Serve as part of a team responsible for defending the clinical development program before regulatory authorities
- Serve as a scientific and clinical resource within Vir Clinical Research
- Provide scientific and clinical guidance to other relevant functions (eg, research, toxicology, clinical pharmacology, development operations, regulatory, project management, etc)
- As appropriate, assist in the clinical evaluation of business development opportunities and provide clinical assessments of relevant drug discovery projects
QUALIFICATIONS AND EXPERIENCE:
- 3+ years' experience preferred 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 preferred
- 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
- 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
- Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
- 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
- MD (or non-US equivalent of M.D. degree) or with sub-specialization in Internal Medicine/Infectious Diseases, or Pulmonary or related fields preferred with 5+ years of experience; PharmD or PhD candidates with 10+ years of 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, one Friday a month 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.