<div class="content-intro"><p><span style="font-family: Arial; font-size: 12pt;">Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit <a href="http://www.azurity.com/">www.azurity.com</a>.</span></p> <p><span style="font-family: Arial; font-size: 12pt;">Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.</span></p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>About the Role: </strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">As part of the Clinical Development team at Azurity, the role requires contribution to clinical programs for product evaluation, development and testing across multiple therapeutic areas.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">In this role, the candidate will report to the Director, Clinical Development and work with stakeholders and team members to provide scientific excellence, build effective relationships across R&D, and ensure optimal design and analysis of clinical investigations.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong> </strong><strong>Key Responsibilities:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Independently lead, author or review the clinical development plan including the clinical protocol and study-related documents viz., pre-IND, IND, NDA documents for respective clinical sections while working with internal and external stakeholders.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Perform literature searches and strategize clinical designing aspects, viz. tentative sample size, study endpoints and duration for Phase 1-3 trials.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Participate in conceptualizing and validating ideas and contribute with clinical inputs and feasibility while closely working with cross-functional teams.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Have the ability to implement study-related operational plans.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Can independently analyze Phase 1 - 2 study data and communicate the results</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Able to oversee and review project-oriented works at external partnered sites and guide wherever necessary.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Attend portfolio team meetings and collaborate with respective program managers in overall project development plan and milestones.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Oversee study oversight including study initiation, monitoring and study closeout and routine follow-up and communication with external partners (CROs).</span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Required Skills and Experience:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum of 6+ years of experience in drug development with extensive experience in Phase 1 clinical pharmacology studies and moderate experience in late phase trials.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Knowledge in ICH guidelines and GCP and sound understanding of regulatory guidelines and clinical requirements.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work experience in 505.b.2 drug development is preferable.</span&g