Corcept Therapeutics
Associate Director, Process Development and Documentation, Clinical Quality Assu
Corcept Therapeutics, Redwood City, California, United States, 94061
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth
is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
The Associate Director of Process Development and Documentation in Clinical Quality Assurance (CQA) is a key member of the CQA team and will lead and perform day-to-day clinical quality operations and compliance activities related to developing and documenting processes to support the success of the clinical studies sponsored or supported by Corcept.
Responsibilities:
Lead process development and documentation activities working with Clinical Development functional teams to support success of the clinical studies sponsored or supported by CorceptLead 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 timelinesServe 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 requiredManage SOP development timelines and plans to ensure compliance with SOP review requirements and regulatory driven updates using risk-based approachLead continuous improvement of the Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP, GLP and GVP compliance and excellenceLead and/or manage and support inspection readiness and preparation activities for development organizationSupport 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 neededSupport 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 SOPsLead and/or support clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checksSupport 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 needsPerform 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 dataMaintain 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 complianceProvide cross training development opportunitiesMentor and coach junior QA team membersMinimal travel requiredPreferred Skills, Qualifications and Technical Proficiencies:
Demonstrated technical writing skills are requiredExperience in process development, mapping and documentationExperience in developing GCP, GLP and GVP processes for the best industry practices and training personnel regarding SOPs and the regulations to which they applyAbility to prepare for and support regulatory agency inspectionsThorough understanding of the quality systems that support internal GCP, GLP and GVP activities for clinical documentation and commercial productsExcellent in basic Microsoft Office applications (Word, Excel, PowerPoint) is requiredPreferred Education and Experience:
BA/BS degree in biological sciences, pharmacy, related field or equivalent experience is required10+ years' experience in process development and specifically developing and maintaining clinical research SOPs for clinical stage pharmaceutical companies
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,300 - $215,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth
is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
The Associate Director of Process Development and Documentation in Clinical Quality Assurance (CQA) is a key member of the CQA team and will lead and perform day-to-day clinical quality operations and compliance activities related to developing and documenting processes to support the success of the clinical studies sponsored or supported by Corcept.
Responsibilities:
Lead process development and documentation activities working with Clinical Development functional teams to support success of the clinical studies sponsored or supported by CorceptLead 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 timelinesServe 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 requiredManage SOP development timelines and plans to ensure compliance with SOP review requirements and regulatory driven updates using risk-based approachLead continuous improvement of the Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP, GLP and GVP compliance and excellenceLead and/or manage and support inspection readiness and preparation activities for development organizationSupport 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 neededSupport 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 SOPsLead and/or support clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checksSupport 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 needsPerform 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 dataMaintain 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 complianceProvide cross training development opportunitiesMentor and coach junior QA team membersMinimal travel requiredPreferred Skills, Qualifications and Technical Proficiencies:
Demonstrated technical writing skills are requiredExperience in process development, mapping and documentationExperience in developing GCP, GLP and GVP processes for the best industry practices and training personnel regarding SOPs and the regulations to which they applyAbility to prepare for and support regulatory agency inspectionsThorough understanding of the quality systems that support internal GCP, GLP and GVP activities for clinical documentation and commercial productsExcellent in basic Microsoft Office applications (Word, Excel, PowerPoint) is requiredPreferred Education and Experience:
BA/BS degree in biological sciences, pharmacy, related field or equivalent experience is required10+ years' experience in process development and specifically developing and maintaining clinical research SOPs for clinical stage pharmaceutical companies
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,300 - $215,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.