Manager, Clinical Development – PBPK

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 www.azurity.com. 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.About the Role: As part of the Clinical Development team at Azurity, the role requires specialization in physiology-based pharmacokinetic (PBPK) modeling who can contribute to early phase clinical programs for developing and evaluating drug products and translational preclinical works. 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: Can independently perform non-compartmental PK analysis to guide study design elements, understand product behavior and utilize parameter estimates for model building Can meta-analyze literature searches, discover the patterns and establish PBPK models guiding formulation development, target dissolution profiles, build IVIVC/R Run simulations with the PBPK/PK models to guide sampling matrix, sample collection and study designing in translational studies Effectively communicate and present the study results internally and externally Able to oversee and review external PBPK/PK-related works and guide wherever necessary Attend portfolio team meetings and collaborate with respective program managers to develop study plans and ensure alignment with overall development plan and timelines Partly oversee study oversight including study initiation, monitoring and study closeout and routine follow-up and communication with external partners (CROs) Contribute to the development, review, and approval of clinical documents like pre-IND, IND, clinical modules, protocols, investigator’s brochure, study plans etc. Required Skills and Experience Minimum of 5+ years in drug development with at least 3 years in early phase clinical development with hands-on modeling & simulation experience preferred. Sound understanding of regulatory guidelin...