Full-Time

Associate Director

Process Development and Documentation, Clinical Quality Assurance

Confirmed live in the last 24 hours

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulators for medical conditions

Biotechnology
Healthcare

Compensation Overview

$183.3k - $215.6kAnnually

Senior

San Carlos, CA, USA

Category
QA & Testing
Quality Assurance
Required Skills
Google Cloud Platform
Requirements
  • Demonstrated technical writing skills are required
  • Experience in process development, mapping and documentation
  • Experience in developing GCP, GLP and GVP processes for the best industry practices and training personnel regarding SOPs and the regulations to which they apply
  • Ability to prepare for and support regulatory agency inspections
  • Thorough understanding of the quality systems that support internal GCP, GLP and GVP activities for clinical documentation and commercial products
  • Excellent in basic Microsoft Office applications (Word, Excel, PowerPoint) is required
  • BA/BS degree in biological sciences, pharmacy, related field or equivalent experience is required
  • 10+ years’ experience in process development and specifically developing and maintaining clinical research SOPs for clinical stage pharmaceutical companies
Responsibilities
  • Lead process development and documentation activities working with Clinical Development functional teams to support success of the clinical studies sponsored or supported by Corcept
  • Lead and/or manage cross-functional teams for the development of GCP, GVP and GLP SOPs. Working with functional areas to support their process development and writing of SOPs and to ensure that SOP reviews and updates are happening within expected timelines
  • Serve as a Clinical Quality Assurance SOP representative and support clinical study teams to provide process compliance advice during team meetings or other methods of communications Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents as required
  • Manage SOP development timelines and plans to ensure compliance with SOP review requirements and regulatory driven updates using risk-based approach
  • Lead continuous improvement of the Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP, GLP and GVP compliance and excellence
  • Lead and/or manage and support inspection readiness and preparation activities for development organization
  • Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigator site inspections, and contract research organization (CRO) inspections. Support GMP, GLP, and PV inspections as needed
  • Support qualification audits of GCP, GLP and GVP service providers, clinical investigator sites, clinical department internal audits, and applicable study document audits, including review of TMFs and CSRs and with specific focus on required and expected SOPs
  • Lead and/or support clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks
  • Support the management and growth of the Clinical Quality Assurance team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs
  • Perform quality metric analysis for CQA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
  • Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to process best practice and SOPs within the pharmaceutical development space. Identify relevant developments, understand impact and develop plans for compliance
  • Provide cross training development opportunities
  • Mentor and coach junior QA team members
  • Minimal travel required

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 an FDA-approved medication for Cushing's syndrome, a condition caused by excessive cortisol. Corcept has created over 1,000 unique cortisol modulators through extensive research and development. Unlike many competitors, Corcept emphasizes both drug development and patient education, providing resources to healthcare professionals and patients to enhance understanding of cortisol-related disorders. The company's goal is to expand its range of treatments for conditions linked to cortisol imbalance while improving patient care.

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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