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.

The Medical Director will collaborate closely with other cross functional team members to ensure the medical integrity of clinical studies. This role involves overseeing medical monitoring, coding, and data cleaning, as well as contributing to the preparation of clinical trial reports and regulatory documents. The ideal candidate will support and manage various safety and data monitoring activities and maintain a high level of expertise in ophthalmologic diseases.

 

Key Responsibilities:

Medical Monitoring & Data Review: Collaborate with Clinical Operations, Data Management and Biostats teams to ensure the accuracy and medical integrity of clinical trial data. Oversee coding and data cleaning activities to maintain data quality and consistency. Review Serious Adverse Event (SAE) reports and ensure timely and accurate documentation. Support data safety monitoring committee (DSMC) meetings, investigator meetings, and clinical site interactions. Provide expert medical oversight and guidance during the conduct of clinical trials. Clinical Data Integrity & Communication: Ensure the medical integrity of clinical studies, providing medical interpretation of clinical trial data. Contribute to the preparation and communication of clinical data, ensuring accurate data interpretation for internal and external stakeholders. Support or prepare clinical trial reports, ensuring accurate data interpretation and adherence to regulatory requirements. Represent the company to external stakeholders, including CROs, clinical consultants, investigational sites, and others involved in the conduct of clinical trials. Clinical Documents Contribute to the preparation of clinical sections of regulatory documents, study synopsis, study protocols, informed consents and investigator brochures ensuring compliance with regulatory requirements and guidelines. Prepare safety charters, DMC charters, and other management plans and manuals in collaboration with cross-functional teams. Ongoing Medical Expertise: Maintain a high level of clinical and scientific expertise in ophthalmologic diseases by reviewing the latest literature and attending relevant medical/scientific meetings.

Qualifications

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-U.S. equivalent of an M.D. degree with clinical development experience. Completion of an Ophthalmology residency program strongly preferred. At least 2 years of clinical trial experience in the pharmaceutical industry. Strong knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials. Experience in developing study synopsis and protocols. Must possess excellent oral and written English communication skills. Travel required: < 20%

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 found at https://www.ocutx.com/privacy-policy/.