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™. We strive to build a strong culture where employees can flourish and achieve their career goals, encouraging out-of-the-box thinking, cross-functional collaboration, and creativity.

About the role

The Senior Director, Clinical Development will serve as a subject matter expert with 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 leads clinical research activities and the design of clinical trials leading to NDA, including endpoint and eligibility criteria development, patient selection for observational and Phases I – III trials. The position oversees clinical trial execution, documentation, analysis, and reporting to prepare regulatory and legislative product approvals.

Responsibilities

• Provide hands-on guidance for all clinical research activities per GCP guidelines leading to NDA and post-approval.
• Create all clinical documents or clinical parts of regulatory documents, including protocols, Investigator’s Brochures (IBs), clinical data reviews, Clinical Study Reports (CSRs), regulatory submissions, and publications or presentations associated with clinical trials.
• Represent Clinical Development in early and late-phase clinical development cross-functional teams/meetings as a senior member.
• Lead the review of accumulating clinical safety data, including protocol deviations, and serve as Medical Monitor for assigned studies.
• Prepare data summaries and presentations for Data Safety Monitoring Committees (DSMC), clinical advisory boards, and other meetings as needed.
• Act as a subject matter expert for regulatory interactions, investigators, expert advisory board meetings, external professional societies, and meetings.
• Collaborate with cross-functional study teams, 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 the creation of clinical development plans.
• Support Clinical Operation Leads and Clinical Project Managers for the successful launch and execution of clinical programs, acting as a contact for the program team and clinical sub-team.
• Serve as the primary contact person independently responding to all study-related inquiries from clinical trial sites and study teams.
• Perform other clinical duties when requested.

Requirements

• MD, PhD, D.O., Pharm D., or 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 in understanding and interpreting scientific and clinical research and literature.
• Demonstrated collaborative behavior, ability to interact and communicate openly and effectively with internal teams, external partners, and 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, and collaborate with Clinical Research organizations in project and program teams.
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), and applicable Standard Operating Procedures (SOPs).
• Experience in the development of protocols, study reports, IBs, and other key clinical documents.
• Ability to thrive in a dynamic, fast-paced environment.
• Dynamic self-starter with a positive attitude and ability to prioritize duties and manage multiple matters from start to finish, demonstrating leadership in change management.
• Excellent written and verbal communication, high-level negotiation skills, and strong presentation abilities.
• Adept, nimble, energetic, and comfortable in a fast-paced, dynamic, and collaborative environment.
• Demonstrated ability to effectively lead multi-disciplinary teams and assimilate new information rapidly.
• Computer literacy with proficiency in MS Office, Excel, PowerPoint, etc.
• Ability to travel approximately 25% for site selection and training, monitoring responsibilities, and educational seminars.

Pay

Salary Range: $247,000 USD - $275,000 USD