Responsibilities and Job Duties
Provides input into, and is accountable for Clinical Operations strategy, clinical trial execution, timelines, resource planning, budget forecasting and study management.
Manages Clinical Operations staff, which may include associate director(s), GTM(s) and COS(s). These staff are focused on all aspects of clinical trial management including administrative, budgetary, resource, and performance management responsibilities.
Provides leadership within the Clinical Operations department, acting as a point of escalation and supports cross-functional issue resolution, as required.
Leads cross-functional matrix 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.
Translates corporate and product development goals into relevant, tangible and measurable objectives for the Clinical Operations team. Tracks project team performance and monitors progress toward corporate and Clinical Operations objectives.
Identifies risks and issues that arise with programs, studies, and sites and makes recommendations and/or implements appropriate measures to address in a timely and effective manner.
Partners 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.
Engages key stakeholders to ensure their expectations of clinical operations are being met or exceeded and responds. Addresses concerns proactively, makes recommendations where necessary and brings to resolution.
Ensures that clinical operations processes, systems and tools are standardized and being utilized, and adequately meet the needs of staff and stakeholders.
Provides direction and guidance to Clinical Operations project teams responsible for clinical trial planning, implementation, management, and close-out.
Ensures compliance and accuracy of Company-sponsored eTMF and CTMS systems.
Maintains awareness of overall developments and benchmarks within the clinical trials ecosystem that impact Clinical Operations, shares best practices with the leadership team to inform and identify process improvement initiatives, that the Director may lead.
Provides mentoring and guidance to assigned staff including administration of performance reviews and development plans. Evaluates resource requirements and ensures that resources are assigned to projects where they are required.
Collaborates with Human Resources to identify talent, recruit, train and develop, and retain team members to provide the highest level of performance and accountability.
Minimum Qualifications
Education & Experience
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
Knowledge, Skills and Abilities
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
Excellent verbal and written communication skills
Experience with early and late phase clinical trials
Proven success in directing global clinical programs
Experience in direct or matrix management of clinical operations team members
Knowledge of the drug development process in the bio/pharmaceutical industry with an understanding of ICH/GCP guidelines, and relevant regulatory requirements
Knowledge of critical path construction and analysis
Understanding of financial principles, budget management and staff utilization
Ability to communicate with and manage senior-level stakeholder objectives
Demonstrated negotiation and persuasion skills
Enthusiasm for innovative research and ability/desire to learn new approaches and expand core skill set
Willingness to travel up to 25%
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