Senior Director, Clinical Development

Position Summary:

Senior Director, Clinical Development will serve as a subject matter expert and have the broad responsibility for the design, development, analysis, and reporting of all clinical studies/trials in accordance with the clinical development plan/strategy and timelines. This role has the primary responsibility for the clinical research activities and design of the clinical trials leading to NDA, all activities for endpoint and eligibility criteria development, patient selection for observational and Phases I – III trials as applicable. Responsible for clinical trial execution including documentation of product trials, analysis and reporting to prepare documentation required for including in the company’s regulatory and legislative product approvals. Responsible for development of clinical protocols to support the company’s product strategy, data collection and management and final reports development in compliance with appropriate standard operating procedures, regulatory and scientific standards. This position requires strong interpersonal and communication skills. This position leads and interacts with various cross functional groups within the company and external to the business to oversee clinical research activities.

Principal Duties and Responsibilities include the following:

• Provide hands-on guidance for all clinical research activities per the GCP guidelines leading to NDA and post-approval
• Responsible for creation of all clinical documents or clinical parts of all regulatory documents including, but not limited to protocols, IBs, clinical data reviews, CSRs, regulatory submissions and publications or presentations associated with the clinical trials
• 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 open 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 board meetings, external professional 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 resolution 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 all the study related inquiries from clinical trial sites and study teams
• Perform other clinical duties when requested

Qualification Requirements:

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