Medical Director

Summary

Join Ocular Therapeutix, a biopharmaceutical company, as their Medical Director. Collaborate with cross-functional teams to ensure the medical integrity of clinical studies. Oversee medical monitoring, coding, data cleaning, and contribute to clinical trial reports and regulatory documents. Support safety and data monitoring activities and maintain ophthalmologic disease expertise. The ideal candidate will have an M.D. or D.O. degree, ophthalmology residency (preferred), at least 2 years of clinical trial experience, and strong knowledge of clinical trial methodology and regulatory requirements. Travel is required less than 20% of the time.

Requirements

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-U.S. equivalent of an M.D. degree with clinical development experience
• 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

Responsibilities

• 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
• 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
• 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
• Maintain a high level of clinical and scientific expertise in ophthalmologic diseases by reviewing the latest literature and attending relevant medical/scientific meetings

Preferred Qualifications

Completion of an Ophthalmology residency program