New

Sr. Manager, Clinical Biomarker Operations

Redwood City, California, United States

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 Sr. Manager, Clinical Biomarker Operations will be responsible for overseeing and supporting various biomarker operational activities across clinical programs. The Sr. Manager will work closely with cross-functional teams, including Clinical Operations, Translational Science, Clinical Science, Quality Assurance, Legal, Pharmacokinetics, and other departments, and Specially Labs to manage biomarker samples, testing, and data.

This role initially requires on-site presence on all days which would change to 3 days per week based on training progress.

Responsibilities:

  • Work with the Translational Scientist to develop a plan for clinical protocol sample management, testing, data management, and relevant documentation through the life cycle of the study
  • Work with the Clinical Operations team to support clinical protocol review, ICF review, and electronic CRF review, specifically regarding biomarker sections
  • Partner with QA when onboarding new vendors for biomarker testing, data analyses, or sample storage, and in the event of any deviation
  • Coordinate with Central and Specialty Labs and Biobank personnel to manage biomarker contracts, samples and data collection, dispositioning and storage following regulatory compliance
  • Develop and maintain robust tracking mechanisms. Manage spreadsheets to track sample collection and disposition, executed as planned through the course of the study
  • Support Clinical Operations and Central or Specialty Labs in managing relevant deviations promptly with decisions based on a strong understanding of scientific and compliance rationales
  • Support contract finalization through Corcept’s online contract management platform and support the Finance team in managing biomarkers’ purchase orders and invoice approvals
  • Participate in developing Standard Operating Procedures (SOPs)
  • Support Translational Scientists in the preparation of CSR, CSR addendums, or other publications
  • Support TMF documentation for all activities involving biomarker samples and data management
  • Contribute to the development and management of the biomarker operations budget for assigned clinical studies
  • Identify potential risks related to biomarker sample and data handling and implement effective mitigation strategies

Preferred Skills, Qualifications and Technical Proficiencies:

  • Detail-oriented with excellent oral and written communication skills
  • Strong team player, flexible and adaptable to a continuously changing environment, self-motivated and able to function independently as well as part of a cross-functional team
  • Proficient in organization, prioritization, and time management
  • Experience with Microsoft Word, PowerPoint, Excel, and Smart Sheets

Preferred Education and Experience:

  • BA/BS degree in a scientific discipline
  • 5+ years of relevant experience in the pharmaceutical industry
  • Experience with sample and data management in clinical trials

The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $200,000; 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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. 

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

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

 

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