Vice President Clinical Operations

*EXCITING NEW CLINICAL OPERATIONS OPPORTUNITY*

VP of Clinical Operations - Fully time - Remote

My Client

I recently spoke to a dynamic biotechnology company dedicated to developing novel therapies to address unmet medical needs. They are committed to advancing cutting-edge research and bringing life-changing treatments to patients worldwide. We are currently seeking an experienced and visionary Vice President of Clinical Operations to lead our clients clinical development programs and drive operational excellence for when this position is open in a months time.

As the Vice President of Clinical Operations, you will play a critical role in shaping and executing our clients clinical research strategy. You will provide strategic leadership, direction, and oversight to our clients clinical operations team, ensuring the successful planning, execution, and management of clinical trials. This position offers an exciting opportunity to lead and grow a clinical operations function in a small biotech company and make a significant impact on the success of our programs.

Responsibilities:

1. Strategic Leadership: Develop and implement the overall clinical operations strategy aligned with the company's goals and objectives. Provide strategic direction and guidance to the clinical operations team to ensure alignment with corporate objectives and regulatory requirements.
2. Clinical Development Planning: Lead the development of comprehensive clinical development plans, including study design, protocol development, and execution strategies. Collaborate closely with cross-functional teams to ensure alignment on study objectives, timelines, and resource requirements.
3. Operational Execution: Oversee the execution of clinical trials, ensuring compliance with protocol requirements, regulatory guidelines, and Good Clinical Practice (GCP) standards. Monitor study progress, identify potential risks and issues, and implement appropriate mitigation strategies to ensure successful trial execution.
4. Team Leadership and Development: Provide leadership, mentorship, and guidance to the clinical operations team, fostering a culture of excellence, collaboration, and innovation. Develop and empower team members to achieve their full potential and contribute to the success of clinical development programs.
5. Vendor Management: Manage relationships with external vendors, including clinical research organizations (CROs), central laboratories, and other service providers. Negotiate contracts, oversee vendor performance, and ensure deliverables are met in accordance with quality standards and budgetary constraints.
6. Regulatory Compliance: Ensure compliance with regulatory requirements, company SOPs, and industry best practices throughout the conduct of clinical trials. Collaborate with regulatory affairs and quality assurance teams to address regulatory inquiries, inspections, and audits as needed.
7. Budget and Resource Management: Develop and manage clinical operations budgets, ensuring efficient allocation of resources and adherence to financial targets. Monitor expenses, identify cost-saving opportunities, and optimize resource utilization to maximize efficiency and productivity.

Qualifications:

• Advanced degree in a scientific or healthcare-related field
• Minimum of 10 years of experience in clinical operations leadership roles within the biotechnology or pharmaceutical industry.
• Strong knowledge of clinical trial conduct, regulatory requirements, and industry best practices.
• Proven track record of successfully leading and managing clinical trials from start-up through closeout.
• Excellent leadership, communication, and interpersonal skills.
• Strategic mindset, with the ability to develop and implement innovative solutions to complex challenges.

How to Apply:

If you are a motivated and experienced Clinical Operations leader looking to contribute to the success of a growing Biotech, we encourage you to apply for this position. Please submit your resume to cburns@barringtonjames.com.