Senior Director, Clinical Development

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the subject matter expert in the design, development, analysis, and reporting of clinical studies and trials.

• Oversee clinical research initiatives and the design of clinical trials that support NDA and post-approval activities.

• Establish endpoint and eligibility criteria while assisting in patient selection for observational and Phase I–III trials.

• Implement clinical trials, which include product-trial documentation, analysis, and reporting required for regulatory and legislative approvals.

• Create clinical protocols, manage data collection and management processes, and produce final reports in accordance with SOPs and regulatory/scientific standards.

• Provide practical guidance for clinical research activities in compliance with GCP guidelines.

• Generate clinical and regulatory documents such as protocols, IBs, clinical data reviews, CSRs, submissions, publications, and presentations.

• Represent Clinical Development in both early- and late-phase cross-functional teams and during regulatory, investigator, advisory board, and professional society meetings.

• Lead the review of accumulating clinical safety data and protocol deviations; act 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 specialists to review, query, reconcile, and resolve clinical study data issues.

• Assist in the development of clinical development plans and ensure the successful launch and execution of clinical programs.

• Serve as the primary contact for study-related inquiries from clinical trial sites and study teams.

• Undertake other clinical responsibilities as needed.

⛳️ Requirements

• MD, PhD, D.O., Pharm D., or RN degree is required.

• A minimum of 5 years of experience in clinical development within the biotechnology/biopharmaceutical industry.

• Strong analytical skills for the interpretation of scientific and clinical research and literature.

• Proven ability to collaborate and communicate effectively with internal teams, external partners, and key opinion leaders while working independently.

• Exceptional detail orientation and organizational skills are necessary.

• Capability to adhere to project plans and timelines while collaborating with Clinical Research Organizations.

• Comprehensive understanding and proven application of FDA guidelines, Good Clinical Practices, and relevant Standard Operating Procedures.

• Experience in developing protocols, study reports, IBs, and other essential clinical documents.

• Ability to thrive in a dynamic, fast-paced environment.

• Skill in prioritizing responsibilities, managing multiple tasks, and driving change.

• Excellent written and verbal communication, negotiation, and presentation abilities.

• Capacity to lead multidisciplinary teams and manage multiple projects simultaneously.

• Proficient in computer skills, particularly in MS Office, Excel, and PowerPoint.

• Willingness to travel up to approximately 25% of the time.

• Experience in ophthalmology clinical trials is highly preferred.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive healthcare coverage including medical, dental, and vision.

• Generous paid time off and flexible work arrangements.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment fostering innovation.