Clinical Development Manager

As a Clinical Development Manager at Azurity Pharmaceuticals, you will play a crucial role in supporting departmental activities related to clinical trials and scientific analyses across therapeutic areas. Reporting to the Associate Director, Clinical Development, you will have the opportunity to contribute to the success of the organization by leveraging your expertise and skills. Your responsibilities will include but are not limited to: - Ability to understand integrated data from clinical trials and other sources to provide scientific evaluations and develop risk assessments. - Providing operational and scientific oversight of nonclinical and clinical studies, ensuring compliance with GCP/ICH/regulatory standards. - Authoring study documents such as protocols, consents, and management plans. - Reviewing CRO/3rd party documents to ensure alignment with quality expectations and SOPs. - Drafting responses to competent authorities or ethical committees. - Monitoring vendors and sites. - Identifying and proposing solutions for logistical, scientific, ethical, and regulatory hurdles. - Providing clinical updates on assigned programs. - Identifying key scientific sources/findings to support clinical development contributions to regulatory communications. - Collaborating with key opinion leaders and external experts/consultants. - Drafting abstracts, posters, oral presentations, and manuscripts. - Contributing to process improvement initiatives within clinical development. - Facilitating contractual requirements for clinical development projects. - Collaborating with the PM function to ensure visibility of project deliverables. Qualifications and Education Requirements: - Degree in a scientific/life-sciences field, with a Masters degree preferred. - 3+ years of experience in clinical development or a related role within the pharmaceutical, biotechnology, or CRO industry. - Working knowledge of clinical research, GCP, GLP, ICH, and FDA regulations. - Understanding of the pharmaceutical drug lifecycle. - Strong communication skills, both written and verbal. - Exceptional analytical and problem-solving skills. - Experience in the analysis of research data and publications. - Passion for research and a willingness to learn. - Bringing innovation and creativity to challenging projects. By applying for this role, you confirm your capability to fulfill the job responsibilities without restrictions. In case of any concerns or disabilities that may affect your ability to perform the job, please inform HR in advance.,