Director, Clinical Pharmacology Reference 15-61 Posted December, 2015 About us: 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. Arbutus Biopharma has offices and research facilities in Burnaby, Canada and Doylestown Pennsylvania, USA. About the role: Arbutus has an opportunity for a Director, Clinical Pharmacology to join our team. Reporting to the Chief Medical Officer the Director, Clinical Pharmacology is responsible for the day-to-day management of Arbutus Biopharma’s Clinical Pharmacology group. If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you. Responsibilities will include: Assume strategic responsibility for the Clinical Pharmacology components of product development from development candidate through lifecycle management post-approval Design, plan, execute and report high quality Clinical Pharmacology studies, including PK, PK/PD, DDI, special population studies in collaboration with Medical/Clinical operations, Translational Research, Regulatory Affairs, Biostatistics and Research and Development colleagues Share cross-functional responsibility for assessing safety, tolerability and pharmacokinetics in clinical study participants. Provide effective Clinical Pharmacology representation on Project teams and extra-departmental activities Contribute relevant clinical pharmacology content to Investigator brochures, clinical study protocols, study reports annual reports and other related documents Represent Arbutus in interactions with regulatory agencies and respond to regulatory inquiries related to PK/PD and Clinical Pharmacology Identify and manage consultants, vendors and CROs supporting Clinical Pharmacology Participate in the evaluation of potential in-licensing candidates and contribute to responses to relevant due diligence requests on Arbutus products Other related duties as assigned Qualifications: MD, PharmD or PhD in a related Life Sciences discipline and minimum 10 years’ experience in a biopharmaceutical environment or equivalent combination of education and experience Minimum 5 years of directly related experience in Clinical Pharmacology and PK/PD within drug development at Pharma or Biotech An experienced, hands-on manager, able to think creatively and strategically, while demonstrating a bias for action Exceptional written and verbal communication, presentation and negotiation skills Expertise with standard modelling and simulation software (eg. NONMEM) Expertise in other non-standard modelling software is an asset Excellent interpersonal skills with a proven track record of building and maintaining strong relationships with internal and external stakeholders Sound judgment and excellent conflict resolution capabilities and an ability to react quickly to changing needs Contact Information: 100-8900 Glenlyon Parkway Burnaby, BC V5J 5J8 e-mail: [email protected] web: arbutusbio.com How to Apply: We invite you to send your cover letter and resume in PDF format, to [email protected]. Please ensure your submission is in PDF format (ideally in one document) indicating your surname in the filename (for example: SmithJane-cover-CV.pdf) and position title and reference number in the subject line of the email (“Director, Clinical Pharmacology (15-61)”). About your Application: At Arbutus we value diversity and encourage applications from all qualified candidates. We greatly appreciate your interest in being a part of our team; however, because of the volume of resumes we receive, we are only able to contact you should you be considered for a position. We will keep your resume in our database for one year, and contact you should a position that matches your skills become available.
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