Executive/Senior Director, Clinical Operations (Sjogren's)

Role Summary

The Executive/Senior Director, Clinical Operations (Sjogren's) will oversee the clinical operations team, enhance global clinical trial operational strategy, and ensure the delivery of clinical studies that meet quality, timeline, budgetary, and regulatory requirements. The Executive Director will lead the management of CROs and other external vendors, foster collaboration across functional teams, and ensure that the clinical strategy is seamlessly integrated into each study’s execution. This role demands exceptional business acumen, leadership skills, and a visionary approach to developing and expanding the team’s competencies.

Responsibilities

• Leads the global operations team to ensure excellence in the execution of all global clinical trials, aligning with the company‚Äôs short-term and long-term goals and objectives.
• Manages CROs and other external partners, ensuring superior collaboration with internal cross functional teams for excellent operational delivery of clinical trials.
• Supervises clinical operation activities including but not limited to feasibility, country selection, regulatory and ethic submissions, site start-up, operational input to the study design, employing risk-based quality management.
• Authorize key clinical trial documents, ensuring all project plans, communication strategies, and operational frameworks align with company standards and regulatory requirements.
• Develops and implements clinical trial performance metrics, leveraging benchmarked key performance indicators and key risk indicators to proactively manage deliverables.
• Leads the CRO selection and negotiating processes, including master service agreements, scope of work contracts, and financial agreements, to optimize resource allocation and budget management.
• Cultivates and strengthens relationships with external vendors, including CROs, holding them to the highest standards of clinical trial delivery.
• Responsible for the clinical trial financial management to guarantee delivery within budget, timelines, and in highest quality.
• Provides updates to management on clinical trial progress, emphasizing performance, risk assessment and mitigation strategies.
• Oversee the development, training, and performance of the clinical operations team, fostering a culture of excellence, innovation, and continuous improvement.
• All other duties as assigned.
• Travel up to 20% as needed.

Qualifications

• Bachelor of Science or equivalent degree required; Master of Science/Advanced degree preferred.
• 12+ years of increasing leadership responsibilities in clinical operations in a pharmaceutical, biotech or CRO company.
• In-depth knowledge of clinical operations and pharmaceutical drug development process in a pharmaceutical or biotech company and in the autoimmune therapeutic area, Sjogren's, preferred
• Proven ability to lead a team, supervise CRO, and collaborate with cross functional teams to deliver global clinical trials with high quality, within budget and on time.
• Thorough understanding of FDA, EMA, and other regulatory requirements, good clinical practices, project management and data handling.
• Experience in leading large multi-country global clinical trials from startup activities, recruitment/retention, to database lock, data analysis, and regulatory submissions.
• Excellent written and verbal communication skills.
• Ability to work cross-functionally in a fast-paced, collaborative environment.
• Strong attention to detail and problem-solving skills.

Skills

• Leadership and people management
• Global clinical trial operations
• Vendor management and CRO oversight
• Budgeting, forecasting, and financial management
• Regulatory submission and compliance knowledge
• Risk-based quality management
• Effective cross-functional collaboration

Education

• Bachelor of Science or equivalent; advanced degree preferred

Additional Requirements

• Travel up to 20% as needed