Executive Director, Clinical Compliance & Inspection
Jobleads-US
Structure Therapeutics Inc. seeks an Executive Director, Clinical Compliance to lead clinical compliance and partner with QA to ensure readiness across Phase 3 programs.
This role oversees TMF health, CRO oversight, CAPA, and inspection readiness, reporting to the Senior VP of CDO. The candidate will guide SOP development, eTMF governance, and performance metrics, while addressing risks across global trials in NA, Europe, and APAC.
#J-18808-Ljbffr Jobleads-US$283k - $325k
...peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments... ..., strategic, and highly motivated Executive Director, Clinical Compliance to lead clinical compliance and, in... ...focus on Phase 3 readiness, inspection planning, and regulatory inspections...SuggestedContract work- ...Executive Director, Clinical Compliance About the Company Innovative biotechnology (BioTech) company Industry Pharmaceuticals Type... ...compliance with regulatory standards and are prepared for inspections and submissions. The Executive Director will be...Suggested
- ...than 750,000 patients worldwide. The Director, Clinical Quality & Compliance is responsible for the strategic oversight, management, and execution of clinical quality assurance and regulatory... ...Practice (GCP), and maintain inspection readiness across all studies, both internally...SuggestedWork experience placementWork at officeLocal areaWorldwideRelocationShift work
- ...Executive Director, Head of Clinical Data Management About the Company A leading biotech firm advancing late-stage clinical programs and regulatory... ...involves driving CRO oversight, vendor management, and inspection readiness, as well as building scalable processes,...Suggested
$337.5k - $393.8k
...Cytokinetics seeks an Executive Director of U.S. Healthcare Compliance to lead compliance strategy and oversight for its cardiovascular drug portfolio. This strategic leader will build and manage the compliance program, chair the Global Healthcare Compliance Committee...Suggested$337.5k - $393.8k
...to improve the lives of people with cardiovascular diseases, we are seeking a strategic leader for the role of Executive Director, U.S. Healthcare Compliance. In support of our launch of MYQORZO® (aficamten), you will lead a small team of compliance professionals as the...$360k - $420k
...Lycia Therapeutics is seeking a Clinical Development Leader to advance their drug pipeline in South San Francisco. This role involves... ...overseeing mid- and late-phase clinical trials, ensuring regulatory compliance, and collaborating with various teams. Ideal candidates have...$300k - $400k
...goal is to fundamentally change the outcomes for these patients. Alumis is seeking an experienced Executive Medical Director or Senior Medical Director to lead clinical development strategy and execution for Phase 1 and Phase 2 studies in neurology and additional new...Remote work- ...Xaira Therapeutics, Inc. in South San Francisco is seeking an Executive Director, Clinical Operations to establish and lead the company’s clinical operations as programs advance from IND into the clinic. Reporting to the Vice President, Head of Early Development, this...
$345k
...Executive Medical Director/Vice PresidentStructure Therapeutics develops life?changing medicines for... ...and peptide drugs. We are advancing a clinical?stage pipeline of differentiated treatments... ...business processes, regulatory, and compliance related to drug development.Travel...- ...South San Francisco, is a clinical-stage biotechnology... ...we are seeking a Senior Director of Quality Systems and Compliance to shape and lead our quality... ..., you will define and execute the global compliance strategy... ...oversight over inspection readiness across the network...Full timeWork at officeLocal areaRemote work2 days per week
- ...aspirations. Join Kite and help create more tomorrows.Job DescriptionWe are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of...Full timeFor contractorsLocal area
- Denali Therapeutics Inc. seeks a senior regulatory affairs leader to develop and execute regulatory strategy for complex development programs in neurodegenerative diseases. You will drive interactions with global Health Authorities, manage submissions, and guide lifecycle...Remote job
- ...Executive Director, Clinical Assessment & Evaluation About the Company Internationally recognized pharmaceutical & diagnostics company Industry Biotechnology Type Public Company Employees 501-1000 About the Role The Company is in search of...Shift work
$250k - $311k
...Executive Director, Clinical OperationsXaira Therapeutics is seeking an Executive Director, Clinical Operations to establish and lead the company... ...submissions, health authority requests, and regulatory inspections.Define and execute the outsourcing strategy across CROs,...Flexible hours$203k - $245k
...Director, Clinical OperationsReporting to the Head of Clinical Operations... ...accountable for the planning and execution of assigned clinical... ...discipline, and regulatory compliance.The Director works closely... ...vendors, risk management, inspection readiness, and the integrity...For contractorsLocal areaRemote workFlexible hours$270.19k - $405.28k
Job Title: Executive Director Clinical Operations, Program Management (Cell Therapy/ Car-T)Locations: US based (Gaithersburg, MD, Boston, MA,... ...franchise strategies, drive standardization, and ensure inspection-ready excellence.How would you set the standard for operational...Hourly payFull timeTemporary workWork at officeFlexible hours3 days per week$345k - $425k
## Executive Medical DirectorApplylocations: South San Franciscotime... .... The Executive Medical Director will serve as a senior medical... ...driving program strategy and clinical development of TV-mediated... ...scientific integrity, regulatory compliance, and alignment with program...Local area$232k - $283k
...diseases. As an Oversight Director, Clinical Operations supporting an asset... ...for the successful execution of multiple studies within... ..., financial oversight, and inspection readiness across your assigned... ...capability. Data Quality, Compliance & Regulatory Readiness Ensure...Contract workInterim role$210.38k - $272.25k
...Management ProgramPosition ImpactThe Director, Global Supplier Quality... ..., and enhances quality, compliance, supply continuity, and... ...program stakeholders.Own and execute the plan and evolution roadmap... ...regulatory requirements and inspection-ready expectations.Drive risk...Full timeFor contractorsLocal area- ...Executive Director, Clinical Development About the Company Rapid-growing biotech company developing oncology therapies Industry Biotechnology Type Privately Held, VC-backed Founded 2022 Employees 11-50 Funding $51-$75 million About the...
$230k - $270k
...in South San Francisco, is a clinical-stage biotechnology company... ...seeking a highly motivated Senior Director, CMC Regulatory Affairs in... ...activities are in compliance with applicable regulations... ...discrepancy management, and inspection management. Assess proposed...Full timeContract workInternshipLocal areaRemote work2 days per week- ...organization is seeking an accomplished Executive Director to provide strategic and operational... ...experience, financial performance, regulatory compliance, workforce leadership, and long-term... ...readiness for regulatory surveys, inspections, audits, and other compliance reviews....Temporary workLocal area
- AbbVie is seeking a senior clinician to lead direction, planning, and execution of one or more clinical development programs. You will partner with cross-functional teams to generate high-quality clinical data supporting product strategy and regulatory submissions. You...
- ...Purpose: Leads the direction, planning, execution, and interpretation of clinical trials or research activities of... ...principles, knowledge of compliance and regulatory requirements, AbbVie... ...work of Medical and/or Scientific Directors working on the same or related programs...
- ...Executive Medical Director position leading clinical development programs for solid tumor oncology at a pharmaceutical company. Directs planning, execution... ...managing cross-functional teams and ensuring regulatory compliance and data integrity. Responsibilities Lead...
- ...Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one... ...scientific principles, knowledge of compliance and regulatory requirements,... ...work of Medical and/or Scientific Directors and of Clinical Scientists working...Full timeLocal area
$166k - $209k
...drugs. We are advancing a clinical‐stage pipeline of... ...continuous improvement, and compliance of Structure... ...Reporting to the Associate Director, GxP Operations, this... ...keep platforms scalable, inspection-ready, and aligned... ...cross-functional teams, executive leadership, and external...Contract workWork at officeRemote work$65 - $70 per hour
...prioritizing their safety and security needs. The Role: Executive Driver Accomplished Security, Inc. is seeking an experienced... ...and ready for immediate use. Conduct routine vehicle inspections and promptly communicate maintenance or mechanical concerns....Hourly payFull timeLocal areaImmediate startFlexible hoursEarly shift$324.62k - $420.09k
...function at Gilead is part of the Clinical Data Sciences (CDS) group... ...Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy... ...scientific rigor, quality and compliance expected by global health... ...documentation, quality and inspection considerations relevant to...Full timeFor contractorsLocal areaImmediate startShift work
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