Senior Director, Clinical Operations

The Sr. Director, Clinical Operations is responsible for the execution of all Phase I - IV clinical trials by study teams, across therapeutic areas. In partnership with other departmental functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, GCP, and company policies to provide timely delivery of high-quality clinical data to support global registration and commercialization of products.Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.This position also encompasses a key role in reviewing and executing departmental strategy, as well as with other senior members managing the day-to-day functioning of the Clinical Operations Department.Responsibilities:Interfaces with key departments to explore methods for continuing high quality and process improvementsContributes to or leads functional and/or cross-functional initiativesContributes input to or identifies to best practices and process improvements / standardizationContributes at the tactical and/or strategic levelIdentifies and contributes to new and the revision of SOPsIdentifies new and novel concepts to resolve complex challengesResponsible for the oversight and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP and corporate and departmental program goals.Maintains oversight of Clinical Operations staff including performance managementManage various direct reports and monitor assigned activities.Contributes to resourcing decisionsReports study updates to senior management (Clinical Program Overview and other Management Team Meetings)Practices professionalism and integrity in all actions and in relationships with Corcept management, supervisors, team members, direct reports and vendors. Exhibits and models leadership behavior through communication and appropriate temperament. Ability to have difficult/crucial conversations with tact. Demonstrated ability to foster and imbue concepts of teamwork, cooperation, self- mastery, and flexibility to get the work done. Maintains composure under difficult circumstances. Develop and monitor Inspection Readiness program and supports BIMO readiness activitiesContributes and maintains the development and review of other department SOPs where Clinical Operations has a role.Manages the incident management program through monitoring of deviations, complaints and CAPAs.Works with Quality Assurance to schedule audits of sites and vendors and supports response and implementation of corrective actions.Develops and maintains controlled documents (forms, templates, and work instructions)Travel required.Preferred Skills, Qualifications and Technical Proficiencies:Extensive clinical research experienceDemonstrated excellence in complex project management and effective management of multiple projects and prioritiesDemonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trialsExperience leading cross-functional teams or work groups as well as direct reportsExperience in presenting to executive staffDemonstrated ability to manage budgetsAbility to initiate, and lead departmental or interdepartmental strategic initiativesPossesses excellent verbal, written, interpersonal skillsDemonstrated strong negotiation and conflict resolution skillsAbility to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelinesMust think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problemsDemonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trialsAbility to contribute to resourcing approach and decisionsDemonstrated ability contributing and documenting processes and process improvementsStrong interpersonal, problem-solving, and organizational skillsSelf-motivated and able to motivate othersSound judgment and discretionAttention to detail and ability to prioritize tasks to meet critical deadlinesStrong organization and time management skillsStrong Proactivity and risk management skillsPreferred Education and Experience:20+ years related experience in life sciences, including 15+ years clinical development experience.A minimum of 15 years of management experience in a clinical research environmentExperience and knowledge of the clinical operations of an investigative site, previous clinical trial experienceManagement experience including outsourcing to Contract Research Organizations (CROs)The pay range that the Company reasonably expects to pay for this headquarters-based position is $243,300 - $286,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.Applicants must be currently authorized to work in the United States on a full-time basis.#J-18808-Ljbffr

Created: 2025-01-01