Cedent Consulting
Director of Clinical Operations
Cedent Consulting, Boston, Massachusetts, us, 02298
Summary:
The Director of Clinical Operations oversees all aspects of clinical operations for a priority immunology program, driving multiple studies across phases I-III. This leadership role requires expertise in clinical operations, strategic planning, and team management. The Director collaborates with cross-functional teams and external partners to ensure that trials are conducted on time, within budget, and to high-quality standards.
Key Responsibilities:
Lead the strategic planning, implementation, and execution of clinical trials for a key immunology program, ensuring adherence to project timelines, budgets, and quality standards.Develop and manage comprehensive program project plans, including protocols, trial budgets, timelines, enrollment strategies, and risk mitigation approaches.Collaborate with internal teams—Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership—to align on clinical objectives and milestones.Provide strategic input for Clinical Development Plans (CDP) to support the overall program strategy.Serve as the primary liaison for CROs and vendors, overseeing performance and ensuring adherence to contractual agreements and quality standards.Ensure compliance with regulatory requirements, ICH-GCP standards, and company SOPs throughout all trial phases.Oversee the collection, analysis, and interpretation of clinical trial data, coordinating closely with Clinical Development, Biostatistics, and Data Management to maintain data integrity.Contribute to the preparation and review of key clinical documents, including the Investigator Brochure, IND, protocols, clinical study reports, and updates to regulatory filings.In collaboration with the Head of Clinical Operations, build and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.Qualifications:
BA/BS in a health-related field; MA/MS in biological, life sciences, nursing, or related field preferred.10+ years of clinical operations experience in the pharmaceutical or biotechnology industry.Proven experience in team building and leadership.Deep knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP guidelines.Strong ability to manage multiple priorities and adapt to a fast-paced environment.Excellent communication, interpersonal, and problem-solving skills.Department:
Direct ClientsThis is a full time position
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The Director of Clinical Operations oversees all aspects of clinical operations for a priority immunology program, driving multiple studies across phases I-III. This leadership role requires expertise in clinical operations, strategic planning, and team management. The Director collaborates with cross-functional teams and external partners to ensure that trials are conducted on time, within budget, and to high-quality standards.
Key Responsibilities:
Lead the strategic planning, implementation, and execution of clinical trials for a key immunology program, ensuring adherence to project timelines, budgets, and quality standards.Develop and manage comprehensive program project plans, including protocols, trial budgets, timelines, enrollment strategies, and risk mitigation approaches.Collaborate with internal teams—Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership—to align on clinical objectives and milestones.Provide strategic input for Clinical Development Plans (CDP) to support the overall program strategy.Serve as the primary liaison for CROs and vendors, overseeing performance and ensuring adherence to contractual agreements and quality standards.Ensure compliance with regulatory requirements, ICH-GCP standards, and company SOPs throughout all trial phases.Oversee the collection, analysis, and interpretation of clinical trial data, coordinating closely with Clinical Development, Biostatistics, and Data Management to maintain data integrity.Contribute to the preparation and review of key clinical documents, including the Investigator Brochure, IND, protocols, clinical study reports, and updates to regulatory filings.In collaboration with the Head of Clinical Operations, build and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.Qualifications:
BA/BS in a health-related field; MA/MS in biological, life sciences, nursing, or related field preferred.10+ years of clinical operations experience in the pharmaceutical or biotechnology industry.Proven experience in team building and leadership.Deep knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP guidelines.Strong ability to manage multiple priorities and adapt to a fast-paced environment.Excellent communication, interpersonal, and problem-solving skills.Department:
Direct ClientsThis is a full time position
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