Associate Director, Data Analytics and Systems Development at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

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
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)
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

Skills

Data Analytics

Systems Development

Project Management

Data Collection

Data Organization

Data Presentation

Trend Analysis

Data Insights

SOP Management

Cross-Functional Collaboration

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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