Senior Director, Clinical Development

🔥 1 minute ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $247k - $275k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Ocular Therapeutix, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Ocular Therapeutix, Inc. is a company dedicated to advancing ophthalmic treatments through innovative technology. The company focuses on developing pharmaceutical therapies and drug delivery solutions for ocular diseases such as retinal diseases, glaucoma, and those requiring ophthalmic surgery. Ocular Therapeutix utilizes its proprietary ELUTYX™ technology to create preservative-free, sustained-release implants, aiming to improve patient outcomes by reducing the frequency of treatments. Their pipeline products include AXPAXLI™ and PAXTRAVA™, alongside marketed products like DEXTENZA® and ReSure® Sealant. The company is committed to enhancing vision health and provides career opportunities within a dynamic and inclusive workplace.

📋 Description

• Serve as subject matter expert for the design, development, analysis, and reporting of clinical studies and trials • Lead clinical research activities and clinical trial design supporting NDA and post-approval activities • Develop endpoint and eligibility criteria and support patient selection for observational and Phase I–III trials • Execute clinical trials, including product-trial documentation, analysis, and reporting for regulatory and legislative approvals • Develop clinical protocols, manage data collection and management, and prepare final reports in compliance with SOPs and regulatory/scientific standards • Provide hands-on guidance for clinical research activities under GCP guidelines • Create clinical and regulatory documents, including protocols, IBs, clinical data reviews, CSRs, submissions, publications, and presentations • Represent Clinical Development on early- and late-phase cross-functional teams and in regulatory, investigator, advisory board, and professional society meetings • Lead review of accumulating clinical safety data and protocol deviations; serve as Medical Monitor for assigned studies • Prepare data summaries and presentations for DSMC sessions, clinical advisory boards, and other meetings • Collaborate with clinical operations, data management, investigators, and other experts to review, query, reconcile, and resolve clinical study data issues • Support creation of clinical development plans and successful launch and execution of clinical programs • Serve as primary contact for study-related inquiries from clinical trial sites and study teams • Perform other clinical duties as requested

🎯 Requirements

• MD, PhD, D.O., Pharm D., or RN degree • Minimum 5 years of clinical development industry experience in the biotechnology/biopharmaceutical industry • Strong analytical skills for interpreting scientific and clinical research and literature • Ability to collaborate and communicate effectively with internal teams, external partners, and key opinion leaders while working independently • Exceptional attention to detail and organizational skills • Ability to comply with project plans and timelines and collaborate with Clinical Research Organizations • Strong understanding and demonstrated application of FDA guidelines, Good Clinical Practices, and applicable Standard Operating Procedures • Experience developing protocols, study reports, IBs, and other key clinical documents • Ability to work in a dynamic, fast-paced environment • Ability to prioritize duties, manage multiple matters, and lead change • Excellent written and verbal communication, negotiation, and presentation skills • Ability to lead multidisciplinary teams and work across multiple projects • Computer literacy and proficiency in MS Office, Excel, and PowerPoint • Ability to travel approximately 25% • Experience in ophthalmology clinical trials is strongly preferred