Azurity Pharmaceuticals - India
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.
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: 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. Perform literature searches and strategize clinical designing aspects, viz. tentative sample size, study endpoints and duration for Phase 1-3 trials. Participate in conceptualizing and validating ideas and contribute with clinical inputs and feasibility while closely working with cross-functional teams. Have the ability to implement study-related operational plans. Can independently analyze Phase 1 - 2 study data and communicate the results Able to oversee and review project-oriented works at external partnered sites and guide wherever necessary. Attend portfolio team meetings and collaborate with respective program managers in overall project development plan and milestones. Oversee study oversight including study initiation, monitoring and study closeout and routine follow-up and communication with external partners (CROs). Required Skills and Experience: 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. Knowledge in ICH guidelines and GCP and sound understanding of regulatory guidelines and clinical requirements. Work experience in 505.b.2 drug development is preferable. Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics. Having proven track record of working with Winnonlin or other PK software (preferred). Strong organizational, interpersonal and both verbal and written communication skills and ability to work collaboratively as a member of a cross-functional team. Good analytical and problem-solving skills. Preferred Qualifications: M.Pharm/ Pharm.D/ Ph.D preferred in the field of clinical pharmacy or pharmacology. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.