Associate Director of Clinical Operations
San Diego, CA - Hybrid
$150,000 - $1800,000
A clinical-stage biotechnology company in San Diego is dedicated to developing transformative medicines for patients with life-threatening diseases. This company focuses on precision medicine, leveraging advanced technologies to create innovative therapies that address significant unmet medical needs. With a robust pipeline targeting various cancer types and other serious conditions, the company is at the forefront of developing next-generation treatments. Supported by a strong leadership team with extensive industry experience and significant funding from top-tier investors, the company is well-positioned for rapid growth and success in the biotech industry. Joining this team means being part of a passionate group committed to making a tangible difference in patients' lives.
Responsibilities:
- Oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements and company standards
- Manage relationships with CROs and other vendors, including contract negotiations and performance monitoring
- Provide direction and support to clinical operations team members, fostering a collaborative and high-performance environment
- Ensure all clinical activities adhere to GCP, FDA, and other regulatory guidelines
- Develop and manage clinical trial budgets, ensuring cost-effective use of resources
- Identify potential risks and implement mitigation strategies to ensure the successful completion of clinical trials
- Ensure the accuracy and integrity of clinical trial data through rigorous monitoring and quality control processes
- Work closely with other departments, including clinical development, regulatory affairs, and data management, to achieve project goals
- Oversee the preparation and review of clinical trial documentation, including protocols, informed consent forms, and study reports
- Identify opportunities for process improvements and implement best practices in clinical operations
Qualifications
- Bachelor's degree in a scientific or health-related field.
- At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting.
- Knowledge of FDA regulations and ICH/GCP guidelines is essential.
- Strong organizational and multitasking skills, with the ability to work in a collaborative team environment.
- Excellent written and verbal communication skills.
- Problem-solving and negotiation abilities, with the ability to adapt as needed.
- Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).
This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
