Director, Development Systems (CTMS & eTMF)

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Director, Development Systems (CTMS & eTMF) is responsible for the strategic oversight and day-to-day operations of Corcept’s pending Clinical Trial Management System (CTMS) that will be used to manage the company’s clinical studies and existing electronic Trial Master File (eTMF) system that is used to store, organize, and manage essential documents related to the company’s clinical trials. This role is key to shaping the systems that support the company’s clinical trials and ensures that both systems align with broader organizational goals. Reporting to the Head of Development Operations, the Director partners closely with leaders in Clinical Operations and IT, and their respective departments.

This is a hybrid role typically requiring on-site presence 3 days per week.

Responsibilities:

Strategic Leadership & Oversight

• Work in close collaboration with Clinical Operations, IT, and our CTMS vendor, lead the implementation of the company’s first in-house instance of CTMS, including defining the intended use of the system, business process flows, and user requirements, and the continued evolution of the company’s eTMF
• Develop and execute change management strategies to maximize adoption and ensure seamless integration of CTMS and eTMF systems within clinical operations
• Drive continuous improvement by establishing a community of internal CTMS and eTMF users, collecting feedback, and identifying system enhancements that optimize business processes and user experience
• Partner with the Head of Business Relationship Management (IT) to co-create and maintain a 3-year roadmap for CTMS and eTMF system enhancements, ensuring alignment with Corcept’s strategic objectives and technology evolution
• Influence cross-functional teams (Clinical Operations, Clinical Records, and IT) to establish and implement effective data management strategies for how the information contained in CRO partners’ Clinical Trial Management Systems and the documents contained in our partner’s eTMFs will be handled
• Partner closely with Clinical Operations, Clinical Records, and IT to create and implement plans for how the information contained in CRO partners’ Clinical Trial Management Systems and the documents contained in our partner’s eTMFs will be handled
• Champion process improvement initiatives, in organizational process improvement efforts, identifying potential opportunities to leverage CTMS or its data to improve efficiency and/or compliance
• Work closely with Clinical Operations and Clinical Records to develop streamlined data entry workflows, and partner with Clinical Operations and Quality Assurance to control CTMS data and eTMF document quality
• Keep current on industry trends, regulatory changes, and GCP requirements, offering strategic guidance on their impact on CTMS and eTMF systems
• Serve as a mentor and advocate for best practices across the organization, fostering a culture of continuous improvement and business impact for CTMS and eTMF
• Depending on business need, this position may have direct reports and would establish, lead and develop the team, including recruiting, training, and providing strategic direction

Operational Excellence & System Oversight

• Ensure systems and their underlying processes are operating as expected, proactively identify and address risks that would prevent optimal functioning, and work with business partners (e.g., IT, system vendors, Clinical Operations) to fix system and process issues when they arise according to service level agreements, if applicable
• Work with business partners to assess the business impact of technical maintenance and system upgrades, minimizing negative impacts to the functioning of the Clinical Operations department and its ability to perform its core responsibilities
• Develop and maintain any associated SOPs or work instructions