Senior Director, Clinical Development
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
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