<div class="content-intro">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>. 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.</div>About the Role: 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. 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. Key Responsibilities: <ul> <li 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.</li> <li 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.</li> <li 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.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Have the ability to implement study-related operational plans.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Can independently analyze Phase 1 - 2 study data and communicate the results</li> <l

Manager, Clinical Development – Clinical Sciences

Job Description