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 Manager of Clinical Safety Operations supports drug safety and pharmacovigilance operation activities for clinical trials. In this role, the individual will be primarily responsible for ensuring end to end safety reporting requirements and processes are established and maintained for clinical trials (phase 1-3). This position may be remote within the United States or hybrid on-site role in Redwood City, CA. In the role, the employee is expected to be onsite and travel (domestic and internationally) to support business needs as/when required, up to 20% of time.
Responsibilities:
- Support the oversight of drug safety service providers to ensure collection, processing, reporting and reconciliation of adverse events reports is compliant with global regulatory requirements and standard operating procedures (SOPs)
- Serve as a Safety Operations Lead on study management team(s)
- Create/revise and implement department SOPs, work instructions and Safety Management Plans (SMPs)
- Develop and deliver training for safety related topics for internal personnel and external vendors
- Perform in line and/or end of line quality review of adverse event reports
- Support process improvement initiatives and safety systems implementation/maintenance activities
- Ensure the clinical trial master file (TMF) is maintained in an inspection ready state for all safety-related documents
- Support and participate in audits and inspections, including preparation activities
- Assist with safety operations and/or safety science projects, as necessary
Preferred Skills, Qualifications and Technical Proficiencies:
- Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
- Excellent communication and collaboration skills in a multidisciplinary team
- Ability to work independently and manage multiple projects in a dynamic, fast-paced environment to meet patient and corporate needs
Preferred Education and Experience:
- Bachelor’s degree in healthcare or life sciences degree such as RN or BSN, PharmD is required
- Minimum of 5 years Drug Safety/PV experience in a global environment
- Experience in both clinical required, and post marketing safety operations preferred
- Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing
The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 – $212,900; 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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Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
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