Corcept Therapeutics
Sr Director, Clinical Operations
Corcept Therapeutics, Redwood City, California, United States, 94061
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, this position 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
Manages 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.
Develops and monitors 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)
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:
Advanced degree desirable
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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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
Manages 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.
Develops and monitors 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)
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:
Advanced degree desirable
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.
#J-18808-Ljbffr