Based in San Francisco and reporting to the Sr. Director, Translational Development in the Clinical Development Department, Vir Biotechnology seeks Director of Toxicology candidates who are highly self-motivated and can work in a collaborative fashion with other interdisciplinary team members in a fast-paced startup that seeks to transform infectious diseases.
Designs and Performs toxicology studies with CROs in collaboration with others on projects pertaining to toxicology studies to support first human dose, investigational new drug, and new drug application program.
Provides analysis and interpretation in preparation for final reports.
Helps ensure regulatory submission and compliance.
Works as part of a multidisciplinary team to bring discovery candidates into development.
Assists in the preparation of documents and annual investigational new drugs and new drugs application reports.
Will work as part of the clinical development team and willing to engage in non-toxicology projects, assisting with infectious diseases pre-clinical (in vitro and in vivo experiments) and clinical (i.e., engaging CROs, reviewing pathogen endpoints assays, help with immunological data acquisition, etc.).
Will work on proof of concepts in the infectious disease area collecting and analyzing data to enable clinical studies.
Generate literature reviews.
QUALIFICATIONS AND EXPERIENCE:
The successful candidate will have the knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of toxicology.
BLA or NDA experience will be highly valued in this search.
Candidate has demonstrated a focus on anti-infective biologics (monoclonal antibodies and/or vaccines).
Excellent scientific written and oral communication skills are required.
Must possess a proven ability to work highly effectively with multiple departments.
Candidate will have to show willingness to learn new areas of expertise.
Must be capable of working with attention to detail in a time sensitive environment.
Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.
Innate flexibility to work in a rapidly growing matrixed environment.
Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
10+ years of relevant experience in industry with PhD in toxicology, and preferably with ID biologics specialization or relevant work.