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Associate Director, Data Analytics and Systems DevelopmentCorcept TherapeuticsUnited States

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Associate Director, Data Analytics and Systems Development

Corcept Therapeutics
  • US
    United States
  • US
    United States

About

Associate Director, Data Analytics and Systems Development
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. Responsibilities:
Lead and/or support systems development, improvement, and documentation activities working with cross functional teams to drive successful outcomes for Corcept studies Lead and/or support the collecting, organizing, storing, and presenting of data, while identifying trends and extracting insights from the data Play a principal role in the formation of the Data Analytics and Systems Development function within the Manufacturing and Pharmacokinetics Teams Maintain and improve tools and systems to track materials including but not limited to drug supply and study samples Develop and keep up-to-date project plans and timelines Manage SOP plans and timelines to ensure that SOP reviews and updates are happening within expected timelines Anticipate issues and proactively mitigate risks and roadblocks Establish MSAs, CDAs, and work orders with Corcept's vendors and partner with the Corcept Finance Department to obtain and submit purchase orders to ensure timely execution of contracts Manage meetings, including agenda preparation, meeting facilitation, documentation, and communication (e.g., distribution of minutes) Facilitate effective communication and decision-making within Manufacturing and Pharmacokinetics teams Provide formal and informal reports and/or slide decks of project status to stakeholders and senior management May take on additional responsibilities as delegated by the head of the Manufacturing and/or Pharmacokinetics teams Support initiatives and continuous improvement as needed Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to best practice within the pharmaceutical development space to identify relevant developments, understand impact and develop plans Preferred Skills, Qualifications and Technical Proficiencies:
Excellent interpersonal, analytical, creative problem-solving, and influence/negotiation skills Experience in developing systems for the best industry practices Demonstrated project management skills and experience supporting cross-functional drug development teams Strong technical writing skills Experience in informatics, mapping, and documentation Excellent in basic Microsoft Office applications (Word, Excel, PowerPoint) Knowledge of regulatory guidelines for drug development functions (ICH and FDA) Preferred Education and Experience:
BA/BS degree in biological sciences, pharmacy, related field or equivalent experience Approximately 10+ years' experience in the biotech/pharmaceutical industry with cross-functional project management experience in developing, improving, and maintaining systems PMP or other Project Management certification/training preferred The pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 - $226,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. This is a hybrid role typically requiring on-site presence at least 3 days per week. Applicants must be currently authorized to work in the United States on a full-time basis. 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. 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.
  • United States

Languages

  • English
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