Corcept Therapeutics

Director, Patient Safety & PV Compliance, Standards, and Training

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Regulatory AffairsIndustries

Requirements

The ideal candidate should possess a Bachelor’s degree in a relevant scientific discipline, such as Pharmacy, Pharmacology, or a related field, and have a strong understanding of pharmaceutical development, regulatory affairs, and pharmacovigilance. Experience in leading and managing compliance programs within a pharmaceutical or biotechnology company is highly desirable, along with demonstrated knowledge of global regulatory requirements including FDA, EMA, and ICH guidelines.

Responsibilities

As the Director, Patient Safety & PV Compliance, Standards, and Training, you will be responsible for the strategic development and execution of PSPV compliance programs, processes, and training for both in-development and marketed products, collaborating closely with various cross-functional teams. This includes overseeing the PSPV Quality Management System, creating and maintaining compliant procedures, developing and implementing PV training programs, managing vendor oversight, ensuring compliance with safety report requirements, supporting system implementation, conducting gap assessments, leading inspection readiness activities, and managing CAPAs to ensure operational excellence and adherence to regulatory standards.

Skills

Regulatory Compliance

Pharmacovigilance (PV)

Quality Management System (QMS)

GxP Regulations

Training Program Development

Vendor Oversight

Safety Reporting

System Implementation

Process Improvement

Inspection Readiness

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.

Key Metrics

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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