Senior Director, Clinical Operations

$243,300 - $286,300/Yr

Corcept Therapeutics - Redwood City, CA

Full-time - Senior

Redwood City, CA

Chemical Manufacturing

About the position

The Senior Director of Clinical Operations at Corcept Therapeutics is responsible for overseeing the execution of all Phase I - IV clinical trials across various therapeutic areas. This role ensures that clinical trial activities comply with applicable SOPs, GCP, and company policies, facilitating the timely delivery of high-quality clinical data for global product registration and commercialization. The position also involves strategic departmental contributions and management of the Clinical Operations team, ensuring effective collaboration and operational excellence.

Responsibilities

• Interface with key departments to explore methods for continuing high quality and process improvements
• Contribute to or lead functional and/or cross-functional initiatives
• Identify best practices and process improvements/standardization
• Contribute at the tactical and/or strategic level
• Identify and contribute to new and revised SOPs
• Resolve complex challenges with new and novel concepts
• Oversee and ensure quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate goals
• Maintain oversight of Clinical Operations staff including performance management
• Manage various direct reports and monitor assigned activities
• Contribute to resourcing decisions
• Report study updates to senior management
• Practice professionalism and integrity in all actions and relationships
• Develop and monitor Inspection Readiness program and support BIMO readiness activities
• Manage the incident management program through monitoring deviations, complaints, and CAPAs
• Work with Quality Assurance to schedule audits of sites and vendors
• Develop and maintain controlled documents (forms, templates, and work instructions)

Requirements

• 20+ years related experience in life sciences
• 15+ years clinical development experience
• 15 years of management experience in a clinical research environment
• Extensive clinical research experience
• Demonstrated excellence in complex project management
• Understanding of pharmaceutical regulatory requirements
• Experience leading cross-functional teams and direct reports
• Experience in presenting to executive staff
• Ability to manage budgets
• Ability to initiate and lead strategic initiatives
• Excellent verbal, written, and interpersonal skills
• Strong negotiation and conflict resolution skills
• Ability to solve complex problems independently
• Attention to detail and ability to prioritize tasks

Nice-to-haves

• Experience and knowledge of the clinical operations of an investigative site
• Management experience including outsourcing to Contract Research Organizations (CROs)

Benefits

• Competitive salary range of $243,300 - $286,300
• Equal Opportunity Employer
• Commitment to employee well-being and professional development