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 located in Warminster, Pennsylvania, USA.
About the role:
Reporting to the Vice President, Clinical Operations, the Director, Clinical Operations will be responsible for managing global phase I-IV clinical programs, will work closely to mentor junior members in Clinical Development and will oversee study conduct and vendor performance to ensure that clinical studies are completed in accordance with contract specifications and corporate objectives.
Responsibilities will include:
• Oversee and manage all operational aspects of phase I-IV global clinical trials;
• Manage direct and indirect reports, external partners, consultants, vendors and budget to ensure the timely, high quality, and cost effective implementation of clinical trials;
• Strategically assess and recommend third party vendors for implementation of clinical development plan. Review and approve contracts, work orders and invoices prior to submission to senior management for approval;
• Establish and maintain effective communication and collaboration with functional area peers including, Regulatory Affairs, Data Management, Legal, Medical, Project Management, Clinical Supply, Finance, etc. to meet program goals and support achievement of corporate objectives;
• Contributes to the development, implementation and maintenance of clinical processes, SOPs and systems;
• Responsible for establishing, maintaining, and reporting clinical program budgets including forecasting and monthly accrual tracking;
• Participate in protocol design and amendment recommendations for clinical trials and ensures appropriate clinical study team review of all trial related documents;
• Oversee clinical trial recruitment, developing or overseeing the development of strategies to ensure effective patient recruitment;
• Ensures Sponsor oversight on all assigned clinical trials in accordance with GCP, all applicable regulatory requirements, and that trials are monitored in accordance to protocol requirements;
• Contributes to development of related regulatory documents including CTAs, and INDs;
• Provides support for clinical study report interpretation and assists in data interpretation;
• In conjunction with Data Management, responsible for data cleaning, line listing review, and study data integrity;
• In conjunction with Clinical Drug Supply, responsible for the delivery of IP and ancillary supply management for assigned studies;
• Other related duties as assigned.
• BA/BS/MS and a minimum of 10 years directly related experience in Clinical Operations Management.
• In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget.
• Sound judgment and excellent conflict resolution capabilities.
• Excellent organizational skills and ability to effectively manage project and/or other cross-functional teams.
• Innovative thinker willing to take measured risks within the bounds of compliance to achieve clinical success
• Embraces process simplification and/or continuous improvement managing any change effectively
• Outstanding communication skills with ability to interact with the Executive Team, capability to negotiate extremely difficult matters and to influence decision makers internally and externally.
• Demonstrates a clear understanding of overall company strategy; aligns people to corporate strategy and vision through words and actions.
• Has a track record of taking a leadership role while introducing new ideas that have significant organizational/team impact.
• Possesses a high tolerance for ambiguity; effectively leads and facilitates change. Flexible and highly adaptable.
• A hands on leader, with excellent problem solving abilities and pro-active nature.