About COUR

COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR’s platform of immune-modifying nanoparticles aims to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression.

About the role

We are seeking an experienced Vice President, Clinical Development Operations to lead our client’s clinical development programs. Reporting directly to the Chief Medical Officer (CMO), the VP of Clinical Development Operations will play a crucial role in overseeing clinical trials, contributing to clinical program design, and ensuring successful execution of development plans.  

What you'll do

• Leadership: Provide leadership over clinical development operations function and professionals, fostering a culture of innovation, collaboration, and excellence.
• Trial Design and Execution: Work with Chief Medical Officer to design Clinical Programs. Oversee the implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
• Regulatory Compliance: Ensure all clinical trials comply with regulatory requirements and industry standards, maintaining high ethical and scientific standards.
• Risk Management: Identify potential risks and develop mitigation strategies to ensure successful clinical trial outcomes.
• Clinical Strategy: Provide input to the design of clinical development strategies aligned with corporate goals and regulatory requirements.
• Collaboration: Work closely with cross-functional teams including regulatory affairs, medical affairs, pharmacovigilance, and commercial teams to integrate clinical development plans into overall business strategies.
• External Partnerships:  Oversee the management of clinical investigators, trial vendors, and other external partners to support clinical trial activities.  Contribute to the management of relationships with key opinion leaders.
• Data Analysis: Provide input into the analysis and interpretation of clinical trial data, ensuring accurate reporting and presentation of results.
• Budget Oversight: Manage clinical development budgets and resources effectively, optimizing allocation to maximize return on investment.

Qualifications

• BS, MS, or PhD in a relevant scientific discipline.
• Minimum of 10 years of progressive experience in clinical development within the pharmaceutical or biotechnology (preferred) industry, with a proven track record of successful drug development.
• Clinical operations experience should be through Phase 3, ideally including drug approval.
• Experience leading in-house clinical trial management, as well as experience with rare disease trials
• Execution oriented with strong leadership skills with experience managing and developing high-performance teams.
• In-depth knowledge of clinical trial design, execution, and regulatory requirements, both US and internationally.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels.
• Strategic mindset with the ability to anticipate challenges and drive innovative solutions
• If remote, travel to home office approximately bi-monthly