Senior Director Clinical Operations

Job Title: Senior Director / Executive Director of Clinical Operations

Company Overview: Join our clients pioneering team, a cutting-edge biotechnology company focused on developing innovative therapies in oncology and neurology. Committed to transforming the lives of patients through ground-breaking research and novel treatments. They are currently seeking an experienced and strategic Senior Director / Executive Director of Clinical Operations to lead their clinical development & operations programs and drive operational excellence.

Position Overview: As the Senior Director / Executive Director of Clinical Operations, you will be responsible for the strategic planning, execution, and management of our clinical trials in oncology and neurology. You will provide leadership and direction to clinical operations team, ensuring the successful delivery of high-quality clinical studies. This role offers a unique opportunity to make a significant impact on the advancement of our therapeutic programs and contribute to the growth of the company.

Responsibilities:

1. Strategic Leadership: Develop and implement the overall clinical operations strategy for oncology and neurology programs. Ensure alignment with corporate goals and regulatory requirements, and provide strategic direction to the clinical operations team.
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 timelines.
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.
8. Stakeholder Communication: Serve as a key point of contact for internal and external stakeholders, providing regular updates on study progress and addressing any concerns or inquiries. Generate study progress reports and presentations for senior management and other stakeholders.

Qualifications:

• Advanced degree in a scientific or healthcare-related field (e.g., MD, PhD, PharmD, or equivalent).
• Minimum of 5 years of experience in clinical operations leadership roles within the biotechnology or pharmaceutical industry, with a focus on oncology and/or neurology.
• 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.
• Ability to thrive in a fast-paced, entrepreneurial environment and adapt to evolving priorities.

Benefits:

• Competitive salary and executive compensation package
• Comprehensive benefits package, including health insurance, retirement plans, and stock options
• Opportunity to work in a fast-paced and entrepreneurial environment
• Chance to make a significant impact on the future of healthcare through innovative clinical development programs in oncology and neurology

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.