At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.
Reporting to the Director of Toxicology, the Manager, Toxicology will oversee the execution and reporting of nonclinical safety studies in support of Arbutus’ drug development programs. The position requires effective interactions and communications with multiple contractors (i.e., nonclinical Contract Research Organizations; CROs) to ensure the alignment of timelines and budgets with the corporate milestones. The Manager may also serve as a Toxicology Representative on project teams and will contribute to the review of nonclinical toxicology documents for regulatory submissions.
Duties and responsibilities:
* Oversees the operational aspects of assigned nonclinical toxicity studies to support product development and regulatory filings.
* Evaluates nonclinical safety capabilities and capacities of CROs, academic institutions and other research facilities for expertise, technical ability, quality, and efficiency; initiates and ensures compliance with Arbutus’ vendor approval process, as required.
* Identifies, selects, qualifies, and establishes relationships with CROs who perform the nonclinical toxicity studies.
* Communicates with CROs to request bids and proposals for conduct of nonclinical toxicity studies. Manages generation of work orders, POs, and invoices.
* On-site monitoring of CROs will be required. Estimated travel ~10-20%.
* Provides critical review and analysis of nonclinical safety data and communicates summarized findings and risks to the Director, Toxicology and other stakeholders.
* Reviews nonclinical toxicity study reports and communicates with CROs until report finalization.
* Contributes to nonclinical sections of regulatory filings, briefing documents, labels, internal reports, standard operating procedures, and presentations.
* Successfully delivers on individual, team, and divisional goals and objectives, as applicable.
* Other related duties as assigned.
* BS or MS degree in a scientific discipline with 3+ years CRO or pharmaceutical industry experience, previous experience in a GLP-regulated environment required.
* PhD in Toxicology or related field with 1-3 years CRO or pharmaceutical industry experience, previous experience in a GLP-regulated environment required.
* Knowledge of drug development and life cycle management concepts and interdependencies with the overall drug development process.
* Ability to design study protocols and to analyze and interpret data for nonclinical safety studies with minimal supervision.
* Familiarity with GLP regulations and ICH, FDA, and EMEA nonclinical safety guidelines.
* Proven ability to manage multiple projects and tasks at one time.
* Excellent written and oral communication skills.
* Must have a keen sense of urgency, superior analytical, organizational, and communication skills, both oral and written.
* Demonstrated track record in preparing reports and written summaries in support of regulatory submissions.
* Experience with small molecule anti-viral drug development is preferred; antibodies and oligonucleotides would be a plus