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.
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 improvements Contributes to or leads functional and/or cross-functional initiatives Contributes input to or identifies to best practices and process improvements / standardization Contributes at the tactical and/or strategic level Identifies and contributes to new and the revision of SOPs Identifies new and novel concepts to resolve complex challenges Responsible 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 management Manage various direct reports and monitor assigned activities. Contributes to resourcing decisions Reports 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 activities Contributes 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 experience Demonstrated excellence in complex project management and effective management of multiple projects and priorities Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials Experience leading cross-functional teams or work groups as well as direct reports Experience in presenting to executive staff Demonstrated ability to manage budgets Ability to initiate, and lead departmental or interdepartmental strategic initiatives Possesses excellent verbal, written, interpersonal skills Demonstrated strong negotiation and conflict resolution skills Ability to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials Ability to contribute to resourcing approach and decisions Demonstrated ability contributing and documenting processes and process improvements Strong interpersonal, problem-solving, and organizational skills Self-motivated and able to motivate others Sound judgment and discretion Attention to detail and ability to prioritize tasks to meet critical deadlines Strong organization and time management skills Strong Proactivity and risk management skills Preferred 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 environment Experience and knowledge of the clinical operations of an investigative site, previous clinical trial experience Management 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.
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