Associate Director, Data Analytics and Systems Development

Corcept Therapeutics•Redwood City, CA

18h•Hybrid

About The Position

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 Associate Director of Data Analytics and Systems Development is a key member of the Manufacturing and Pharmacokinetics teams. This position will play a critical role in achieving Corcept’s Goals by supporting the Manufacturing and Pharmacokinetics teams by providing expertise in systems development, project management, and in collecting/summarizing/presenting data.

Requirements

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)
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

Nice To Haves

PMP or other Project Management certification/training preferred

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