Director, Clinical Development

Role Summary:

Reporting to the Vice President, Clinical Development, the Director, Clinical Development will provide hands-on execution of Arbutus Biopharma’s clinical research programs and will have overall responsibility for clinical development activities and deliverables.

Key Responsibilities:

• Engages and provides leadership in all clinical development activities from Phase 1 through Phase 3 leading to product registration.
• Participates in developing and executing the clinical strategy for development programs with senior management and cross-functional development teams, including authoring protocols and other clinical trial-related documents.
• Interacts with key opinion leaders to promote scientific dialogue regarding Arbutus’ clinical stage programs as well as key developments in the field.
• Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
• Ensures that clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical trial implementation and execution.
• Ensures work with colleagues and collaborators is coordinated and that all people, systems, processes and materials required for clinical trial execution are available and appropriately prepared.
• Liaises with clinical investigators and key opinion leaders to establish global clinical trial footprint and monitor progress of trials.
• Analyzes and interprets clinical data and current literature and prepares appropriate reports, meeting presentations and papers.
• Prepares and writes reports required for Regulatory Submissions coordinating with Regulatory Affairs as appropriate, and attends meetings, presents plans and data to regulatory agencies as necessary.
• Other related duties as assigned.

Qualifications:

• MD, DO, or equivalent medical training with 3-5 years of Pharmaceutical Industry experience in early or late clinical development.
• Knowledge of ICH and GCP Guidelines and Regulations as they apply in the biotechnology/pharmaceutical industry is essential.
• Strong team presence with demonstrated effectiveness interacting respectfully, ethically and cross-functionally at all levels both internal and external.
• Ability to travel for meetings and conferences, up to 20% travel time.
• Excellent written and verbal communication skills, as well as outstanding analytical abilities and presentation skills.
• Comfortable working both internally and externally with technical and medical experts in providing input into drug development strategies.
• Fast learner with ability to deal with technical and business issues with equal skill and able to deal with many ambiguities inherent in an emerging pharmaceutical company without becoming rigid or mechanical.
• Emotional maturity and ability to effectively facilitate change in an environment where the structure may evolve rapidly.