Senior Director, Clinical Compliance & Inspection Readiness
Structure Therapeutics
Structure Therapeutics seeks an Executive Director, Clinical Compliance to lead clinical compliance and operational readiness across early and late-phase programs, with a focus on Phase 3 readiness and inspections. You will establish scalable, risk-based processes, strengthen CRO/vendor oversight, and drive continual improvement. The role collaborates with Clinical Operations, QA, Regulatory Affairs, Data Management, Biostatistics, and other functions, reporting to the SVP, CDO. #J-18808-Ljbffr Structure Therapeutics
$283k - $325k
...We are advancing a clinical‐stage pipeline of differentiated... ...motivated Executive Director, Clinical Compliance to lead clinical... ..., operational readiness across the company’s... ...Phase 3 readiness, inspection planning, and regulatory... ...will report to the Senior Vice President,...SuggestedContract work- ...Executive Director, Clinical Compliance About the Company Innovative biotechnology... ...and are prepared for inspections and submissions. The... ...execution and inspection readiness. Applicants must have a BA... ...7 years in a Director or Senior Director role. The role requires...Suggested
- ...Therapeutics Inc. seeks an Executive Director, Clinical Compliance to lead clinical compliance and partner with QA to ensure readiness across Phase 3 programs.... ...health, CRO oversight, CAPA, and inspection readiness, reporting to the Senior VP of CDO. The candidate will...Suggested
- ...Therapeutics Inc. is seeking an Executive Director, Clinical Compliance to lead clinical compliance and, with QA, ensure readiness across early and late-stage... ...focus on Phase 3 readiness and inspections. The role reports to the Senior VP of Clinical Development Operations...Suggested
- ...headquarters in South San Francisco, is a clinical-stage biotechnology company... ...milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and lead our quality... ...strategic oversight over inspection readiness across the network, quality systems...SeniorWork at officeLocal areaRemote work2 days per week
$250k - $311k
...Executive Director, Clinical Operations Xaira Therapeutics is seeking... ...and data organization, and senior leadership. The Executive Director... ...requests, and regulatory inspections. Define and execute the... ...operations inspection readiness, including preparation for...SeniorFlexible hours- ...used for more than 750,000 patients worldwide. The Director, Clinical Quality & Compliance is responsible for the strategic oversight, management... ...and Good Clinical Practice (GCP), and maintain inspection readiness across all studies, both internally managed and externally...Work experience placementWork at officeLocal areaWorldwideRelocationShift work
$166k - $209k
.... We are advancing a clinical‐stage pipeline of differentiated... ...Position Summary:The Senior Manager, Clinical... ...improvement, and compliance of Structure... ...Reporting to the Associate Director, GxP Operations, this... ...platforms scalable, inspection-ready, and aligned with evolving...SeniorContract workWork at officeRemote work- IDEAYA Biosciences in South San Francisco seeks a Medical Director of Patient Safety and Pharmacovigilance to lead medical review of... .... The position collaborates with Safety Operations to ensure timely, inspection-ready safety reporting. #J-18808-Ljbffr IDEAYA BiosciencesSenior
$275k - $295k
...experienced and motivated Clinical Operations Lead to... ...inflammatory diseases. As the Director and Lead of Clinical... ...interactions and inspections. Clinical Trial... ...within budget, and in compliance with global regulatory... ...ensure high‑quality, audit‑ready datasets. Implement and...Senior- ...Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing... ...Clinical Trial Manager (CTM)/Senior Clinical Trial Manager (Sr. CTM). Reporting... ...and corrective action plans. Compliance: Ensure "inspection-ready" Trial Master Files ( TMF ) and compliance...SeniorFull timeFlexible hours
$230k - $270k
...South San Francisco, is a clinical-stage biotechnology company... ...seeking a highly motivated Senior Director, CMC Regulatory Affairs in... ...development activities are in compliance with applicable regulations... ...management, and inspection management. Assess proposed...SeniorFull timeContract workInternshipLocal areaRemote work2 days per week- ...own the QMS and serve as the Management Representative. This senior leadership role partners with Regulatory and Operations to... ..., set the quality strategy, oversee FDA QMSR, ISO 13485, and related standards, and ensure readiness for inspections. #J-18808-Ljbffr CytovaleSenior
$163k - $191k
...Humankind!Vaxcyte is a clinical-stage vaccine... ...and experienced Senior Manager, Clinical... ...teams to ensure compliance with regulatory requirements... ...Issues, Audits, Inspections or during similar... ...inspection readiness activities,... ...Reports to: Senior Director, Clinical Quality...Senior3 days per week- A national recruiting company is seeking a skilled Project Manager to oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal candidates...Senior
- ...Vaxcyte seeks an experienced Senior Manager of Clinical Quality Assurance to lead quality investigations, audits, and compliance activities across clinical development programs... ...system Support regulatory inspection readiness including mock inspections and gap assessments...Senior
$143.23k - $185.35k
...process robustness, facility controls, contamination control, and inspection-readiness narratives relevant to individualized patient manufacturing.... ..., and risk-based justifications.Advise on comparability and clinical bridging needs for rapid process evolution, analytical...SeniorFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours$255k - $335k
...headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering... .... About the role: The Medical Director will lead the execution of an oncology... ...environment dealing with Regulatory Inspection Readiness * Excellent organizational skills and...InternshipWork at officeLocal areaRemote work$203k - $245k
...Director, Clinical Operations Reporting to the Head of Clinical Operations, the Director... ..., fiscal discipline, and regulatory compliance. The Director works closely with... ...budgets, vendors, risk management, inspection readiness, and the integrity of operational data...For contractorsLocal areaRemote workFlexible hours$230k - $300k
...programs, led by a potential first‑in‑class clinical asset and complemented by an exciting... ...large commercial opportunities.Are you ready to transform lives and be part of a... ...to meeting you.The RoleWe are seeking a Director or Senior Director of Clinical Pharmacology to lead...SeniorContract work$175k - $215k
...diseases. As Trial Master File (TMF) Senior Manager for Clinical Operations, you will serve as the... ...to maintain complete, accurate, and inspection-ready Trial Master Files for ongoing... ...resolution of document gaps, and sustained compliance with GCP and regulatory...Senior$226.19k - $292.71k
...of passionate and ambitious people ready to make a direct impact.We believe... ...patients for generations to come.As the Senior Director - U.S. Ethics & Compliance Advisor (HIV), you will act as the... ...across Legal, Commercial, Medical, Clinical Development to build and integrate...SeniorFull timeFor contractorsLocal area- ...Regulatory Affairs Manager or Director to lead a critical 510(k)... ...with R&D, Quality Assurance, Clinical Affairs, and other SMEs to gather... ...standards to ensure ongoing compliance. Support regulatory project... ...Audits, and regulatory inspections. Participate in internal and...Senior
- ...Senior Director, Clinical Pharmacology Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan's mission to develop multiple targeted treatments in parallel...Senior
$218.06k - $327.09k
...Job Title: Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs Location: South... ..., or Gaithersburg -MD, USA Are you ready to steer the global regulatory strategy... ...for product maintenance and compliance activities associated with marketed brands...SeniorHourly payTemporary workWorldwideFlexible hours3 days per week- Zai Lab Limited is seeking an experienced Clinical Pharmacology leader to head the Clinical Pharmacology function and advise on strategy, modeling, and regulatory support across its portfolio. The role requires global collaboration with development, translational sciences...Senior
$210.4k - $331.1k
...Job Description The Senior Director, Clinical Data Intelligence & Medical Monitoring Innovation... ...including input on timing, sequencing, user readiness, and communication of new... ...conviction records for employment in compliance with the San Francisco Fair Chance Ordinance...SeniorFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$232k - $283k
...common and rare diseases. As Director of Clinical Operations, you will serve... ..., and maintain continuous inspection readiness. The successful candidate... .... Data Quality, Compliance & Regulatory Readiness... ...information Influences Senior Management decisions through...Interim role$222.48k - $259.56k
...Cytokinetics seeks a Director of Clinical Quality Assurance to lead global quality strategy... ...quality assurance team, ensuring GCP compliance across international regulatory environments, and directing audit and inspection readiness activities. Responsibilities Lead...$232k - $283k
...diseases. As an Oversight Director, Clinical Operations supporting an... ...financial oversight, and inspection readiness across your assigned asset... ...Agreements. Serve as the senior operational escalation... ...capability. Data Quality, Compliance & Regulatory Readiness...Contract workInterim role
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