Job Title: Associate Director of Clinical Operations
Location: Seaport, Boston, MA
Company 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 bonuses
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Generous paid time off and holidays
- Professional development opportunities
