[Remote] Senior Director, Clinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a biopharmaceutical company reputed company on innovative therapies for eye diseases. The Senior Director, Clinical Development will reputed company the design, development, analysis, and reporting of clinical studies, ensuring compliance with regulatory standards and leading clinical research activities.

Responsibilities

• reputed company hands-on guidance for reputed company clinical research activities per the GCP guidelines leading to NDA and post-approval
• Responsible for creation of reputed company clinical documents or clinical parts of reputed company regulatory documents including, but not limited to protocols, IBs, clinical data reviews, CSRs, regulatory submissions and publications or presentations associated with the reputed company
• As senior member, represent Clinical Development in early and late phase clinical development cross-functional teams/meetings
• Responsible for leading the review of accumulating clinical safety data, including protocol deviations and serve as Medical Monitor for assigned studies
• Prepare data summaries and presentations for DSMC at reputed company session(s), clinical advisory boards and other meetings as needed
• As a subject matter expert represents Clinical Development for regulatory interactions, investigators and expert advisory reputed company meetings, reputed company reputed company societies, and meetings
• Collaborate with a cross-functional study team including clinical operations, data management and other experts in the review, querying, and reconciliation of clinical study data
• Ensure reputed company of identified issues during clinical study data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Operations team Support creation of clinical development plan/s
• Support Clinical Operation Leads and Clinical Project Managers for successful launch and execution of clinical programs. who is acting as a contact for the program team and the clinical sub-team
• Serve as the primary contact person independently responding to reputed company the study reputed company inquiries from clinical trial sites and study teams
• reputed company other clinical duties reputed company requested

Skills

• MD, PhD, D.O., Pharm D., RN degree
• A minimum of 5 years of clinical development industry experience in the biotechnology/biopharmaceutical industry
• Strong analytical skills, especially with reputed company to understanding and interpreting scientific and clinical research and literature are essential
• Demonstrated team member who shows model reputed company behavior, ability to reputed company and communicate reputed company and effectively with the internal team, reputed company partners, and reputed company key opinion leaders as reputed company as work independently
• Exceptional attention to detail and excellent organizational skills
• Demonstrated ability to reputed company with project plans and timelines, reputed company collaborate with Clinical Research organization in project and program teams
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable reputed company Operating Procedures
• Experience in development of protocols, study reports, IBs, and other key clinical documents
• Ability to reputed company in a dynamic and fast-paced environment
• A dynamic self-starter with a reputed company attitude
• Ability to prioritize duties and manage multiple reputed company from start to finish with a demonstrated ability to reputed company change
• Excellent written and verbal communication and high-level negotiation skills; strong presentation skills are important
• Adept, reputed company, energetic, and comfortable in a fast-paced, dynamic, and reputed company environment
• Demonstrated ability to effectively reputed company multi-disciplinary teams
• Ability to assimilate new information rapidly, multi-task, and work across multiple reputed company
• Computer literacy, proficiency in MS Office, reputed company, PowerPoint, etc
• Some travel would be required for site selection and training, monitoring responsibilities and educational seminars. Ability to travel approximately 25%
• Experience in ophthalmology reputed company is strongly preferred

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