Regional Director of Operations.

The Role

Headlands Research is seeking a highly motivated, and seasoned operations leader looking for an opportunity to support and empower site leaders to grow and lead efficient site operations. This individual should bring a strong background in the clinical trial industry with specific experience in research trial execution and multi-site leadership. Candidates should appreciate the atmosphere of a growing company and the need to impact process development while supporting sites. Success in this position requires agility, collaboration and exceptional critical thinking and problem-solving abilities.

Duties

• Operations oversight of approximately 6-8 DeNovo and/or integrated clinical trial sites within an assigned region
• Successfully integrate newly acquired sites into Headland’s network processes, systems, workflows, etc.
• Collaborate with sites and central recruitment services as applicable to ensure sites meet targeted enrollment goals for all studies
• Lead and develop site leaders (direct reports) through exceptional people management skills and collaboration to influence positive operational outcomes
• Build strong partnerships with Site Directors/Presidents, Business Development, PI’s and central support teams to identify opportunities for strategic site growth and operational excellence
• Ensure operational, quality, and financial standards, systems and practices are in place and each site receives the necessary central support to achieve its objectives
• Work with site leaders and Finance business partners on forecasting and budgeting resulting in continuously improved revenue and expense management
• Support strategy for site level recruitment, training, and employee development to ensure sites are adequately staffed for current and future demand
• Conduct in person visits to sites on a regular cadence based on site needs
• Plan and set individual and site goals and track the progress of each to ensure that objectives are met
• Serve as primary point of escalation for Site Directors in resolving operational challenges
• Collaborate with site leaders and Quality and Training business partners to ensure GCP quality standards are in place and all quality and regulatory requirements are adhered to
• Support site sponsor interactions by acting as a point of escalation and providing confidence in site operations
• Conduct monthly financial and operations reviews with sites to include KPI's, employee and patient retention & enrollment, capacity, revenue, and expense management
• Participates and presents at meetings with internal and external representatives as needed
• Identify opportunities to expand business within the region through new therapeutic capabilities, equipment, or site development
• Collaborate with the business development team to assess site capabilities
• Facilitate performance improvement monitoring and discussions between site staff and human resources
• Additional project work as assigned

Requirements:

• Education – Bachelor's degree in business or a health-related field required; master’s degree preferred
• 5 years + experience in clinical trials industry (sponsor, IRB, CRO, site)
• Proven success in a multi-site healthcare leadership role- experience leading multiple sites and teams across several geographic locations
• Demonstrated ability to successfully manage people/projects across a continuum of experience, knowledge, and diversity.
• Proactive problem-solving abilities and follow-through
• General understanding of GCP, CFR, and state regulations as applicable
• Results oriented- demonstrates strong business planning skills, communicates objectives clearly to teams, reviews, and monitors KPI’s and provides coaching and mentoring to achieve goals
• Driven- self-starter, excellent time management skills, ready to execute in a tactical and strategic manner, holds themselves and others to high standards of accountability
• Collaborative- ability to develop relationships and collaborate along the vertical
• 5 years + experience managing direct reports
• Superior communication skills, written and verbal including emails and presentations both internal and external with sponsors and CROs
• Displays professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done timely with a high degree of responsiveness with multiple stakeholders
• Knowledgeable and able to confidently speak in the following areas of clinical research

• Business Development
• Finance/Accounting
• Human Resources
• Legal
• Clinical Development / Key Therapeutic Areas such as CNS/Psych/Metabolic/Endocrine/Vaccines
• Recruitment
• Information Technology
• Business Operations