Senior Director, Clinical Development

ding 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 inclusion 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 and 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
• 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 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, clinical advisory boards and other meetings as needed.
• Represent Clinical Development for regulatory interactions, investigators, 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 investigative sites in collaboration with the Clinical Operations team. Support creation of clinical development plans.
• Support Clinical Operation Leads and Clinical Project Managers for successful launch and execution of clinical programs; act as a contact for the program team and the 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.

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.
• Demonstrated team member who shows collaborative behavior, ability to interact and communicate openly and effectively with internal and external partners and key opinion leaders, and ability to work independently.
• Exceptional attention to detail and excellent organizational skills.
• Demonstrated ability to comply with project plans and timelines; collaborate with Clinical Research organization in project and program teams.
• Excellent understanding and 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 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%.

Salary Range: $247,000 – $275,000 USD

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy. For the Privacy Notice for California job applicants, please see the California Consumer Privacy Act applicant notice.