Clinical Operations Director
2 months ago
**Clinical Operations Director**
Our client is a leading provider of expanded access clinical trials. This company is seeking an experienced Clinical Operations Director to join their growing team. In this pivotal role, you will oversee the end-to-end operational execution of its expanded access programs, ensuring seamless delivery and high-quality data capture.
**Responsibilities**:
- Manage the operational planning, site selection, regulatory compliance, and logistics for its expanded access clinical trials across a variety of therapy areas, with a focus on neurodegenerative and oncology indications
- Collaborate closely with the medical, data management, and project management teams to ensure efficient trial conduct and timely delivery of results
- Develop and implement robust operational strategies, policies, and procedures to support the scalability and quality of the expanded access programs
- Provide expert guidance and oversight to the clinical operations team, fostering a culture of continuous improvement
- Serve as the primary point of contact for site staff, CROs, and other external partners involved in the expanded access trials, leveraging your experience in site feasibility, study start-up, and regulatory negotiations
- Identify and mitigate operational risks, proactively addressing challenges to ensure successful trial execution
- Contribute to the development of innovative operational approaches that enhance the patient experience and data quality of the expanded access offerings
Qualifications:
- 8+ years of progressive experience in clinical operations, with a strong track record of leading expanded access or other non-traditional clinical trials, ideally including time as a Clinical Research Coordinator at an academic research center
- Demonstrated expertise in managing the operational complexities of expanded access programs, including site management, supply chain logistics, and regulatory compliance
- Excellent project management skills, with the ability to coordinate multiple stakeholders and competing priorities
- In-depth understanding of GCP guidelines and other relevant regulatory requirements
- Exceptional communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and build strong relationships with site staff
- Proven leadership abilities, including the capacity to mentor and develop a high-performing clinical operations team
- Bachelor's degree in a life sciences or healthcare-related field; advanced degree preferred
**A strong-willed and resilient mindset is essential, as the successful individual will play a pivotal role in shaping the company's operational infrastructure and scaling the business. If you are energized by the challenge of building something transformative from the ground up, this is an unparalleled opportunity to make a lasting impact in the clinical research industry.**
Pay: $100,000.00 - $150,000.00 per year
**Benefits**:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Schedule:
- Monday to Friday
Application Question(s):
- Do you have any prior experience/ exposure to Expanded Access programs?
**Experience**:
- Clinical Operations: 6 years (required)
Ability to Relocate:
- San Jose, CA: Relocate before starting work (required)
Work Location: In person
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