Associate Director, Data Analytics and Systems Development

Role Summary

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. This is a hybrid role typically requiring on-site presence at least 3 days per week.

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

Qualifications

• 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)

Education

• 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

Additional Requirements

• Hybrid role typically requiring on-site presence at least 3 days per week