<p><span style="color:#021b58"><b><span style="font-size:14px">We offer integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging our deep scientific, medical, and regulatory expertise and real-world experience. Our goal is to help you complete projects efficiently and with less risk, leading to solutions for a healthier and safer world.</span></b></span></p><p></p><p><span style="color:#021b58"><b><span style="font-size:14px">With a broad range of renowned scientific, medical, regulatory, and engineering specialists under one roof, we streamline your project and reduce your workload, so you can make sound, science-based decisions about human and environmental health issues.</span></b></span></p><p></p><p><span style="color:#021b58"><b><span style="font-size:14px">BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. Across these specialized areas, we collaborate to deliver science-driven solutions that support industries including pharmaceuticals, biotechnology, medical devices, chemicals, foods and consumer products. Our collective expertise helps clients navigate regulatory requirements, assess safety and efficacy, manage risks, and optimize pharmaceutical commercialization strategies.</span></b></span></p><p></p><p><span style="color:#021b58"><b><span style="font-size:14px">If you’re ready to achieve your life science goals, there’s no better partner than BlueRidge Life <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Sciences. </span></span></b></span></p><p></p><p><b><u>Job Description:</u></b></p><p>The Vice President, Clinical Strategy leads clinical operations programs, providing vision, management, and daily execution. Program(s) goals, milestones and deliverables are achieved via close interaction and collaboration with all functional lines involved in clinical development for Clintrex clients. Responsibilities include operational leadership and successful execution of clinical trials according to regulatory guidelines, oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables; oversight and continuous improvement of department infrastructure through the development of SOPs, guidelines and the use of technology; facilitation of effective internal and external relationships, and achievement of project goals and objectives. The VP, Clinical Strategy will also play an integral role in supporting the clinical development and regulatory affairs team for client encounters and monthly contracts. Additionally, the VP, Clinical Strategy will help with overall BRLS strategy and integration. Specific responsibilities for this role will include but are not limited to: </p><p></p><ul><li>Work with Clintrex and client clinical operations team to oversee execution of clinical trials </li><li>Provide a key role in on-going study analysis from an operational standpoint </li><li>Frequent communication with sites and KOLs to ensure study is conducted to the highest standards </li><li>Work with clinical operations team to develop new synopses/protocols or provide review of study protocol/synopses</li><li>Provide insight and assistance with the CRO selection process for clients</li><li>Provide budget oversight and assistance for clinical trials</li><li>Help build out additional clinical operations team as necessary </li><li>Participate in review of regulatory documents and other clinical documents for clients</li><li>Help clients with the selection and management of vendors </li><li>Provide clinical development and operational expertise to clients as part of encounters or monthly contracts</li><li>Assist with reach out to sites for study conduct or client support needs </li><li>Assist with overall BRLS integration<br> <br> <br> <br><b>Requirements:</b> </li><li>10 years of progressive clinical <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">operations/development</span> experience in pharmaceutical/drug development, with a preference for neurology/orphan drug experience </li><li>Proven track record of planning, conducting & managing clinical operations for Phase 1-4 studies </li><li>Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors. </li></ul><ul><li>Experience managing the clinical operations for drug across multiple therapeutic areas is a plus </li><li>Track record of leading a cross-functional team in a matrix environment </li><li>Experience in a hands-on early development role within a small organization is a plus. </li><li>Demonstrated ability to handle a high volume of highly complex tasks within a given timeline </li></ul><p></p><p></p><p></p><p>. </p><p></p><p></p>
