Innovative clinical-stage biotech with multiple assets and a unique platform is looking for a Director of Clinical Operations to provide strategic vision and direction as the business grows. As a leader in the company, you will be responsible for growing the team, and setting the standards for the strategy and processes required for successful life cycle management across the therapeutic portfolio.
Armed with an incredibly strong pipeline, we are now looking for a new Director, Clinical Operations to drive the team forward in this period of growth.
Responsibilities and Job Duties
- Defining the Clinical Operations strategy, clinical trial execution, timelines, resource planning, budget forecasting and study management
- Managing a Clinical Operations team focused on all aspects of clinical trial management including administrative, budgetary, resource, and performance management responsibilities
- Providing leadership within the Clinical Operations department, acting as a point of escalation and supports cross-functional issue resolution, as required
- Leading cross-functional teams whose mission is to deliver high quality and timely execution of clinical development plans including the setup, conduct and reporting of clinical trials
- Provides strategic, tactical and operational input to Product Development Teams to ensure appropriate planning and to drive better decision making
- Partnering with Clinical Operations Outsourcing team to oversee and coordinate all budgetary activities for assigned programs including project budget creation, forecasting, accruals reporting and invoice approval and to oversee and coordinate all budget-related activities for vendors and clinical trial sites.
- Engaging key stakeholders to ensure expectations their expectations of clinical operations are being met or exceeded and responds. Addresses concerns proactively, makes recommendations where necessary and brings to resolution
- Ensuring that clinical operations processes, systems and tools are standardized and being utilized, and adequately meet the needs of staff and stakeholders
- Maintaining awareness of overall developments and benchmarks in Clinical Operations and shares best practices with leadership team to drive change and improvement
- Collaborating with Human Resources to identify talent, recruit, train and develop, and retain team members to provide the highest level of performance and accountability.
- Bachelor’s degree, preferably in health care, life sciences, or related discipline
- A minimum of 10 years of experience within a clinical operations team in the Biotech/Pharmaceutical industry
- A minimum of 5 years of successful experience managing people and vendors
- Several years of experience managing Phase I, II and Phase III clinical studies in immune-oncology
- Thorough understanding of the processes associated with executing a clinical development program including: clinical trial design, implementation, management and reporting
- Advanced leadership, project management, resource management, administrative and technical capabilities
- Advanced knowledge of Oncology clinical trial design, implementation and management
- Understanding of Oncology therapies and practice as it relates to clinical trial design
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