The Associate Director of Clinical Operations is integral to overseeing the planning, coordination, and execution of global clinical trials. This role is responsible for ensuring adherence to project milestones, managing financial aspects, and upholding quality standards in line with ICH/GCP guidelines, regulatory requirements, and internal SOPs. The position involves crafting and implementing study execution strategies and leading a team of direct reports.
The Associate Director cultivates a supportive environment that values authenticity and open communication. Committed to scientific advancement and thoughtful risk management, they collaborate across teams to develop innovative solutions for both technical and business challenges. They proactively identify risks and create mitigation strategies to drive success in clinical operations through strategic vision and effective teamwork.
Key Responsibilities:
- Oversee clinical operations for assigned programs, ensuring compliance with GCP, ICH, and relevant regulations.
- Manage global studies, directing Clinical Trial Managers and CRO Study Teams.
- Contribute to clinical development planning and strategy.
- Lead the selection and management of CROs, and oversee investigator recruitment, study start-up, enrollment, data collection, and drug projections.
- Develop and manage project timelines to achieve departmental and corporate goals.
- Identify and implement strategies to address study risks.
- Track KPIs for assigned trials, including clinical reviews and data query resolution.
- Provide senior management with timely updates on progress and changes in scope.
- Oversee the preparation and content of investigator meetings.
- Coordinate site outreach and enrollment activities.
- Communicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and Finance.
- Contribute to clinical study reports, Investigator's Brochures, protocols, and other regulatory documents.
- Ensure the Clinical Trial Master File is current and inspection-ready.
- Assess enrollment feasibility across various indications.
- Lead or co-lead the development of clinical documents and study-related plans.
Professional Experience / Qualifications:
- Comprehensive knowledge of industry practices, outsourcing, and GCP system requirements.
- Strong collaborative skills and the ability to build effective relationships across departments.
- Documented training in FDA Regulations, GCP, and ICH guidelines.
- Excellent communication and writing skills.
- Effective in influencing and relationship-building.
- Strong problem-solving skills and sound judgment.
- Detail-oriented with experience managing and developing direct reports.
- Willingness to travel domestically and internationally (10-15%).
- Experience with regulatory authority inspections is a plus.
Preferred Education:
- B.A. or advanced degree in biological sciences or a related field.
Preferred Experience:
- At least 10 years of experience in clinical operations within biotech, pharmaceutical, or CRO environments, including 5 years managing global clinical trials.
- Experience in both early and late phases of development and in immune-mediated diseases.
Preferred Computer Skills:
- Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.