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Associate Director Clinical Operations
149994
Posted:
11/09/2024
- 180000 USD - 180000 USD
- South San Francisco, United States
- Permanent
Job Title: Associate Director, Clinical Operations
Location: South San Francisco, CA (Onsite 3 days per week)
Job Type: Full-time
Position Summary:
Our client is seeking an experienced and driven Associate Director of Clinical Operations to lead our global Phase 3 clinical trials. The successful candidate will have substantial experience in managing Phase 3 studies, a proven track record as an independent study lead for at least 3 years, and ideally some experience in people management. This role requires a strategic leader who excels in operational excellence and team collaboration to ensure the successful execution of clinical trials.
Key Responsibilities:
- Oversee and manage global Phase 3 clinical trials, ensuring compliance with regulatory requirements, study protocols, and project timelines.
- Act as the primary study lead, independently managing all facets of trial execution, including protocol development, site management, and data collection.
- Collaborate closely with cross-functional teams, including Clinical Development, Data Management, Regulatory Affairs, and Medical Affairs, to ensure alignment and successful trial outcomes.
- Provide leadership and guidance to study teams, including mentoring and managing staff to enhance team performance and development.
- Develop and maintain strong relationships with key stakeholders, including external vendors, clinical sites, and regulatory bodies.
- Monitor trial progress, identify potential risks, and implement corrective actions to ensure timely and efficient study completion.
- Prepare and present regular updates and reports to senior management and other key stakeholders.
Qualifications:
- Bachelor's degree in Life Sciences or a related field; advanced degree (e.g., Master’s, Ph.D.) preferred.
- At least 7 years of experience in clinical operations, with a strong focus on global Phase 3 studies.
- Demonstrated experience as an independent study lead for a minimum of 3 years, with a proven ability to manage complex trials effectively.
- Prior experience in a people management or leadership role is highly desirable.
- In-depth knowledge of clinical trial design, regulatory guidelines, and industry best practices.
- Exceptional organizational, communication, and problem-solving skills.
- Ability to work onsite in South San Francisco 3 days per week.