Director, Clinical Operations

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    "requisitionDescription": "<div><div><div><div><div><div><p><span style=\"font-family: Arial;\"><strong>NO AGENCIES - PLEASE!</strong></span></p><p><em>Please note: &nbsp;This position requires the individual to be on-site (no remote work). &nbsp;Relocation assistance is not provided.</em></p><p><br></p><p data-pasted=\"true\"><strong><span style=\"font-size: 14px;\">POSITION SUMMARY:</span></strong></p><p><span style=\"font-size: 14px;\">The Director of Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed-upon timelines and budgets. This role reflects the knowledge, experience, skill levels, and capacity to manage complex studies or programs.</span></p><p><span style=\"font-size: 14px;\"><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES:</strong></span></p><p><span style=\"font-size: 14px;\">Strategic Planning:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Develop and execute strategic plans for clinical trial operations, ensuring alignment with the company&#39;s overall goals and objectives.</li><li style=\"font-size: 14px;\">Collaborate with the cross-functional &quot;core&quot; teams to integrate clinical operations strategies into broader development plans.</li></ul><p><span style=\"font-size: 14px;\">&nbsp;</span></p><p><span style=\"font-size: 14px;\">Clinical Trial Management:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Oversee the design, planning, and execution of clinical trials, including Phase I-III studies, ensuring adherence to timelines, budgets, and quality standards.</li><li style=\"font-size: 14px;\">Lead the selection and management of Contract Research Organizations (CROs) and vendors involved in clinical trials.</li><li style=\"font-size: 14px;\">Monitor clinical trial progress and identify and mitigate risks and issues that may impact timelines or data quality.</li></ul><p><span style=\"font-size: 14px;\">&nbsp;</span></p><p><span style=\"font-size: 14px;\">Regulatory Compliance:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Ensure all clinical operations activities are conducted in compliance with applicable regulatory guidelines, including Good Clinical Practice (GCP) and local regulations.</li><li style=\"font-size: 14px;\">Collaborate with regulatory affairs to support regulatory submissions and interactions with health authorities.</li></ul><p><span style=\"font-size: 14px;\"><br></span></p><p><span style=\"font-size: 14px;\">Resource Management:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Build and manage a high-performing clinical operations team, including hiring, training, and development of staff to oversee studies.</li><li style=\"font-size: 14px;\">Oversee the allocation of resources, including budget management and forecasting for clinical trial activities</li></ul><p><span style=\"font-size: 14px;\">&nbsp;</span></p><p><span style=\"font-size: 14px;\">CRO Collaboration:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Manage and collaborate effectively with CRO partners, ensuring their performance aligns with project timelines, quality standards, and budgetary constraints.</li><li style=\"font-size: 14px;\">Manage vendor relationships and negotiate contracts to ensure efficient and cost-effective clinical trial execution.</li></ul><p><span style=\"font-size: 14px;\">&nbsp;</span></p><p><span style=\"font-size: 14px;\">Data Management and Analysis:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Collaborate with data management and biostatistics teams to ensure data collection, analysis, and reporting are of the highest quality.</li><li style=\"font-size: 14px;\">Review and interpret clinical trial data to support decision-making and data-driven insights.</li></ul><p><span style=\"font-size: 14px;\">&nbsp;</span></p><p><span style=\"font-size: 14px;\">Quality Assurance:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Implement and maintain quality assurance processes to ensure the integrity of clinical trial data and compliance with regulatory standards.</li></ul><p><span style=\"font-size: 14px;\">&nbsp;</span></p><p><span style=\"font-size: 14px;\">Continuous Improvement:</span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Drive continuous improvement initiatives within clinical operations processes to optimize efficiency and effectiveness.</li><li style=\"font-size: 14px;\">Other duties, as assigned.</li></ul><p><span style=\"font-size: 14px;\"><strong>&nbsp;</strong></span></p><p><span style=\"font-size: 14px;\"><strong>QUALIFICATIONS</strong><strong>:</strong></span></p><ul type=\"disc\"><li style=\"font-size: 14px;\">Ph.D. is preferred; however, Master&rsquo;s Degree in life sciences or a related field would be the required minimum. &nbsp;</li><li style=\"font-size: 14px;\">Minimum of 10 years of experience in clinical operations within the biotechnology or pharmaceutical industry, with significant experience in CNS therapeutic areas.</li><li style=\"font-size: 14px;\">Proven track record of successful leadership in managing and executing Phase II-III clinical trials.</li><li style=\"font-size: 14px;\">Strong understanding of regulatory requirements and GCP guidelines.</li><li style=\"font-size: 14px;\">Excellent leadership and team-building skills.</li><li style=\"font-size: 14px;\">Exceptional communication and interpersonal skills.</li><li style=\"font-size: 14px;\">Strategic thinker with the ability to make data-driven decisions.</li><li style=\"font-size: 14px;\">Proven ability to work collaboratively in a cross-functional environment, do what is right, create value, and achieve the extraordinary.</li></ul><p><span style=\"font-size: 14px;\"><br></span></p><p><span style=\"font-size: 14px;\"><br></span></p><p><br></p></div></div></div></div></div></div>\n",
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