Director, Clinical Operations

<div> <p class="MsoNormal">An expanding company in Rockville, MD is looking for a <strong>Director</strong> to oversee clinical operations, vendor relationships, site management, and contract negotiations.</p> <p class="MsoNormal"> <p class="MsoNormal"><strong>Responsibilities:</strong></p> <div>· <strong> </strong><strong>Supervise and develop a clinical team</strong> while participating in the creation and writing of clinical trial protocols.</div> <div>· Lead the identification and selection of clinical sites, manage trial agreements, and handle budget discussions.</div> <div>· <strong>Identify, onboard, and oversee external partners </strong>such as CROs, central IRBs, and clinical labs.</div> <div>· Manage vendor contracts and budgets throughout the entire clinical trial process.</div> <div>· <strong>Forecast investigational product needs </strong>and manage inventory.</div> <div>· Review and approve clinical study documents including SAPs, EDC design, validation, study reports, and more.</div> <div> </div> <div> </div> <div> </div> <p class="MsoNormal"><strong>Qualifications:</strong></p> <div>· Bachelor&#8217;s degree and 12+ years of experience in clinical operations, with expertise in vendor management and budget oversight.</div> <div>· <strong> </strong><strong>4+ years experience in a services organization</strong>, preferably in pharmaceuticals, biotechnology, or contract research.</div> <div>· <strong>6+ years of team leadership experience</strong> and handling complex projects.</div> <div>· Experience with IND and NDA submissions.</div> <div>· Strong analytical and critical thinking skills, with sound judgment in fast-paced environments.</div> <div>· <strong> </strong><strong>Demonstrated leadership abilities</strong> with a coaching mindset and collaborative approach.</div> <div>· Skilled in building professional relationships and communicating effectively with all levels of an organization.</div> <div>· Exceptional written and verbal communication skills for engaging with teams and stakeholders.</div> </div>