Full-Time

Manager – Clinical Safety Operations

Posted on 12/12/2024

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulators for medical conditions

Biotechnology
Healthcare

Compensation Overview

$144.8k - $212.9kAnnually

Senior

No H1B Sponsorship

San Carlos, CA, USA

This position may be hybrid on-site in Redwood City, CA.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary

You match the following Corcept Therapeutics's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
  • Excellent communication and collaboration skills in a multidisciplinary team
  • Ability to work independently and manage multiple projects in a dynamic, fast-paced environment to meet patient and corporate needs
  • Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD is required
  • Minimum of 5 years Drug Safety/PV experience in a global environment
Responsibilities
  • Support the oversight of drug safety service providers to ensure collection, processing, reporting and reconciliation of adverse events reports is compliant with global regulatory requirements and standard operating procedures (SOPs)
  • Serve as a Safety Operations Lead on study management team(s)
  • Create/revise and implement department SOPs, work instructions and Safety Management Plans (SMPs)
  • Develop and deliver training for safety related topics for internal personnel and external vendors
  • Perform in line and/or end of line quality review of adverse event reports
  • Support process improvement initiatives and safety systems implementation/maintenance activities
  • Ensure the clinical trial master file (TMF) is maintained in an inspection ready state for all safety-related documents
  • Support and participate in audits and inspections, including preparation activities
  • Assist with safety operations and/or safety science projects, as necessary
Desired Qualifications
  • Experience in both clinical required, and post marketing safety operations preferred
  • Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing stress, metabolism, and immune functions. 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 healthcare professionals and patients to improve understanding and care for cortisol-related conditions. The goal of Corcept Therapeutics is to lead in cortisol modulation and enhance treatment options for patients suffering from disorders linked to cortisol imbalance.

Company Stage

IPO

Total Funding

$39.7M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

3%

1 year growth

2%

2 year growth

-3%
Simplify Jobs

Simplify's Take

What believers are saying

  • 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.

What critics are saying

  • 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.

What makes Corcept Therapeutics unique

  • 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.

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Benefits

Remote Work Options

Flexible Work Hours

INACTIVE