Associate Director of Clinical Operations

Job Title:Associate Director of Clinical OperationsLocation:Seaport, Boston, MACompany Overview:We're partnered with a biotech that's dedicated to developing innovative therapies for neurodegenerative diseases. Their mission is to improve the lives of patients through cutting-edge research and clinical development.Position Overview:The Associate Director of Clinical Operations will play a pivotal role in overseeing and managing clinical trials focused on neurodegenerative diseases. This position requires a strategic leader with extensive experience in clinical operations, project management, and regulatory compliance. The successful candidate will collaborate with cross-functional teams to ensure the successful execution of clinical trials from initiation to completion.Key Responsibilities:Clinical Trial Management:Oversee the planning, implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.Team Leadership:Lead and mentor a team of clinical operations professionals, fostering a collaborative and high-performance work environment.Vendor Management:Select, manage, and oversee Contract Research Organizations (CROs) and other external vendors to ensure quality and compliance with study protocols.Regulatory Compliance:Ensure all clinical trials are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.Data Management:Collaborate with data management teams to ensure accurate and timely data collection, analysis, and reporting.Risk Management:Identify and mitigate risks associated with clinical trials, implementing corrective actions as necessary.Budget Oversight:Develop and manage clinical trial budgets, ensuring cost-effective use of resources.Stakeholder Communication:Serve as the primary point of contact for internal and external stakeholders, providing regular updates on trial progress and addressing any issues that arise.Quality Assurance:Implement and maintain quality management systems to ensure the highest standards of clinical trial conduct.Qualifications:Education:Bachelor's or Master's degree in Life Sciences, Nursing, or a related field. Advanced degree (Ph.D., M.D.) preferred.Experience:Minimum of 10 years of experience in clinical operations within the biotechnology or pharmaceutical industry, with a focus on neurodegenerative diseases.Leadership:Proven track record of leading and managing clinical operations teams.Regulatory Knowledge:In-depth knowledge of GCP, FDA regulations, and other relevant guidelines.Project Management:Strong project management skills with the ability to manage multiple priorities and projects simultaneously.Communication:Excellent written and verbal communication skills, with the ability to effectively communicate with diverse stakeholders.Problem-Solving:Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing challenges.Benefits:Competitive salary and performance-based bonusesComprehensive health, dental, and vision insurance401(k) with company matchGenerous paid time off and holidaysProfessional development opportunities#J-18808-Ljbffr

Created: 2025-03-05