Clinical Operations, Senior Director/Vice President
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Reporting to the Chief Medical Officer, the Senior Director / VP of Clinical Operations is responsible for the strategy, planning, overall conduct and timely execution of clinical trials, and is a key contributor to the development and execution of the clinical program strategy in close collaboration with other key stakeholders (e.g. Regulatory Affairs, Technical Operations, Quality Assurance). He/she is accountable for budget planning and management and for identifying and mitigating risks for clinical operations activities across the Agios portfolio. He/she will also be accountable to lead and develop the entire Clinical Operations organization.
Ensure that goals and objectives of the clinical development program are met by providing strategic and tactical input into the planning and execution of clinical trials.
Provide operational oversight of clinical trials, ensuring that they are completed on time and within approved budget, and conducted and monitored in accordance with GCP/ICH.
Develop and maintain the contract research network to support clinical trials, including selection, contracting, management, and oversight of Contract Service Providers and their budgets.
Oversee selection of investigators for clinical trials; plan and lead Investigators meetings in partnership with the Medical function.
Forecast investigational product needs; oversee supply chain with Technical Operations.
Lead and manage the Clinical Operations team to function effectively and cohesively, with a focus on performance, mentorship, coaching, and career development as appropriate.
Manage the Clinical Operations budget, forecast, and resource allocation; establish departmental goals in support of corporate objectives and ensure staff has aligned goals.
Ensure compliance with Clinical and GCP/ICH guidelines, and lead the development of new and periodic revision of existing Clinical SOPs.
Participate in and contribute to cross-functional strategic discussions pertaining to the drug development program, and drafting of the Clinical Development Plan.
Oversee and participate in preparation of clinical study documents, including Protocols and Amendments, Investigator s Brochure, Informed Consent Forms, Clinical Study Reports.
Assist in preparing clinical module documents for regulatory submissions, including annual reports, and preparing publications and presentations of the clinical trial results.
Provide Clinical Operations oversight during preparation for and conduct of inspections.