Full-Time

Safety Science Director

Confirmed live in the last 24 hours

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulators for medical conditions

Biotechnology
Healthcare

Compensation Overview

$243.3k - $286.3kAnnually

Senior

San Carlos, CA, USA

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Requirements
  • PhD, PharmD or other advanced degree in related discipline is preferred. Other relevant experience may be considered without an advanced degree; BS/BA degree in related discipline is required.
  • 6+ years in experience in patient safety and pharmacovigilance in the capacity of a scientist with a focus in post-approval setting; at least 2 years of clinical development experience is required.
  • Authoring and review of periodic and ad hoc safety reports (more than 3 years of experience required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries).
  • Experience in writing safety analyses, performing signal detection or safety surveillance, risk management and preparing responses to HA.
  • Experience with NDA/MAA filing.
  • Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
  • Knowledge of ICH guidelines and GVP.
Responsibilities
  • Perform safety analyses through appropriate data selection, review of case series, data summaries and/or AE trend information, including data from clinical trials and post marketing.
  • Conduct review of medical and scientific literature for signal detection and aggregate reporting activities.
  • Lead the preparation and development of safety reports/ deliverables, including Integrated Summaries of Safety (ISS).
  • Work closely with safety physicians and liaise with cross-functional stakeholders and teams on signal detection and risk management activities.
  • Mentor, train and collaborate with junior scientists on signal detection and risk management activities.
  • Lead the development and maintenance of Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies (REMS) for assigned product(s). As required, develop a product-specific Safety Plan. Perform safety data monitoring, analysis, and interpretation. Maintain good documentation. Communicate safety profile effectively (written and verbal) both internally and externally.
  • Prepare and review aggregate safety reports for assigned product(s).
  • Provide safety input to statistical analysis plans and data analysis visualizations, and similar documents requiring significant safety analysis. Ensure consistent presentation of safety and risk management topics across various regulatory documents. Contribute to and/or review safety sections of clinical documents, including Investigator’s brochure (IB), clinical study protocols, clinical study reports.
  • Work closely with safety physicians and liaise with cross-functional stakeholders in authoring the safety sections of a regulatory package (e.g., NDA, Briefing Document). Lead in the creation of health authority or other safety related query responses for assigned product(s).
  • Participate in safety governance meetings and support safety deliverables related to cross functional or benefit-risk assessment meetings, including creation and maintenance of product core safety information and company core data sheets (CCDSs).
  • Support PV vendor oversight, continuous process improvement, and inspections and audits.
  • Provide scientific and technical leadership to support discovery and development project teams.
  • Maintain up to date knowledge related to technical area of expertise including areas of disease, drugs, data interpretation and integration, and regulatory and business environment.

Corcept Therapeutics focuses on developing treatments that regulate cortisol, a hormone important for stress response, metabolism, and immune function. Their main product, Korlym, is the first FDA-approved treatment for Cushing's syndrome, a condition caused by excessive cortisol. The company has discovered over 1,000 selective cortisol modulators and aims to expand its offerings with new treatments in development. Unlike many competitors, Corcept emphasizes both research and patient education, providing resources to improve understanding and care for cortisol-related conditions. The goal of Corcept is to advance the treatment of serious medical conditions linked to cortisol imbalance.

Company Stage

IPO

Total Funding

$42.6M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

23%

1 year growth

31%

2 year growth

53%
Simplify Jobs

Simplify's Take

What believers are saying

  • Significant investments from firms like Intrinsic Edge Capital and Jackson Creek Investment Advisors indicate strong market confidence in Corcept's growth potential.
  • The appointment of experienced leaders like Roberto Vieira and Monica Tellado suggests a strategic focus on expanding into oncology and emerging markets.
  • Corcept's commitment to patient and medical education enhances its reputation and fosters better patient outcomes.

What critics are saying

  • Ongoing legal disputes, such as the antitrust lawsuit from Teva, could result in financial and operational setbacks.
  • The loss of the Korlym patent lawsuit to Teva poses a significant threat to Corcept's revenue stream from its flagship product.

What makes Corcept Therapeutics unique

  • Corcept Therapeutics specializes exclusively in cortisol modulation, setting it apart from broader-focused biopharmaceutical companies.
  • Their flagship product, Korlym, is the first FDA-approved treatment for hypercortisolism in Cushing's syndrome, giving them a unique market position.
  • Corcept's extensive R&D pipeline with over 1,000 discovered selective cortisol modulators highlights their commitment to innovation in this niche field.

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