Associate Director- Clinical Virology
AstraZeneca

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago



This job has expired.

Job Description

Major Duties and Responsibilities:
We are seeking a Clinical Virologist with bioinformatics training and virology drug, diagnostic, oncolytic virus or vaccine development experience to join the Microbial Sciences Department at AstraZeneca! The candidate will provide outstanding scientific leadership to support the development of novel antibodies and vaccines for the prevention and/or treatment of viral infections in our infectious disease portfolio. As part of the Translational Science group, you will integrate expertise/findings from discovery research, nonclinical and clinical groups to impact therapeutic programs from inception through to life cycle management for marketed drugs.

This role will support a team of scientists and clinicians developing novel vaccines and antibodies to prevent or treat Influenza, Rhinoviruses, hMPV, Respiratory Syncytial Virus, Coronavirus, as well as other viral targets in the AstraZeneca portfolio.
Key responsibilities include:

  • Contribute to development of biomarker strategies and clinical protocols for virology targets, ensuring delivery within cross-functional project teams
  • Provide oversight of laboratories performing virology testing in clinical trials and epidemiology studies
  • Design and coordinate studies with companies to evaluate diagnostics and Next Generation Sequencing approaches
  • Design and execute studies to understand monoclonal resistance to antibodies
  • Coordinate surveillance studies in the U.S., Europe and developing world with academic and non-government organizations
  • Prepare documentation of validation efforts using scientific principles
  • Manage Global CRO's focused in Clinical Virology
  • Provide virology support for regulatory communications and filings
  • Able to travel a minimum of 10% overnight
  • Motivated to expand horizons within the vaccines and biologics industry

This is a high profile role and requires an individual with outstanding technical, communication and project management skills as well as the ability to build strong relationships with key partners in Clinical, Research, Regulatory and other functions within AstraZeneca; to include external, academic, and contract research collaborators. The individual must also be able to work with a fast-paced and product development organization to provide data and reports in a timely manner. The successful candidate is expected to contribute to publications in top-tier scientific, technical or medical journals.
Qualifications
Education:
  • PhD in Virology or relevant scientific field (e.g. molecular biology, immunology, genetics, epidemiology, bioinformatics)
Experience:
  • 5+ years of clinical virology experience in evaluating anti-viral drugs, vaccines or diagnostics in clinical trials or epidemiology studies
Special skills/abilities
  • Experience with sequencing technologies and performing bioinformatic analyses of large data sets
  • Molecular biology and virology and cell-based assays to measure viral fitness or susceptibility and/or resistance to novel drugs
  • Outstanding record of contributions in drug or vaccine development for viral diseases particularly for influenza and RSV as evidenced by publications
  • Knowledge of (GCPs) and (GLPs)
  • Outstanding verbal and written communications skills are a must
  • Have successful consultative, strategic planning and organizational skills working in a matrix environment
  • Have a demonstrated ability to influence and build rapport with highly regarded Health Care Professionals and Key External Experts in virology and drug development fields
  • Familiar with ICH guidelines for assay validation and implementation


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