Senior Director, Clinical Operations Inspection Readiness Leader
Regulatory Jobs
Generate:Biomedicines is seeking a Senior Director, Clinical Operations Business & Excellence to set strategy for a centralized Clinical Operations Business Office that embeds inspection readiness into trial execution. You will own the operating model, governance, and portfolio performance, aligning clinical sourcing, site contracting, TMF operations, and CAPA follow‑through.
Reporting to the Head of Clinical Operations, you will translate portfolio priorities into scalable processes, drive
#J-18808-Ljbffr$275k - $285k
...Senior Director, Clinical OperationsCambridge, Massachusetts or Oakland CaliforniaAt... ...Director, Clinical Operations will provide strategic... ...requires a collaborative leader who is equally comfortable... ...regulations while maintaining inspection readiness.Drive continuous...SeniorFull timeContract workLocal area$219k - $329k
...The Role: Generate is seeking a Senior Director, Clinical Operations Business & Excellence to set the... ...Operations Business Office that embeds inspection readiness into clinical trial execution.... ...serve as a senior cross‑functional leader, align stakeholders on complex...SeniorContract workWork at officeRemote workShift work$253k - $300k
...to deliver significant clinical benefit to a wide range... ...Job Summary As the leader of the cross-functional... ...Clinical Program Team, the Senior Director Clinical Operations (SDCO) will lead the planning... ...Clinical Practice and inspection readiness across studies....SeniorContract workLocal area- ...week onsite) Reporting to SVP Clinical Operations About Hemab Hemab is building... ...Copenhagen, Denmark. The role As Senior Director, Clinical Operations, you'll lead... ...maintaining ICH-GCP compliance and inspection readiness. Lead and develop Clinical...SeniorShift work2 days per week3 days per week
- ...Metaphore Biotechnologies is seeking a Senior Director of Clinical Operations to lead the hands-on execution of... ..., with particular focus on Phase 1 readiness and execution. The successful... ...established quality standards. Maintain inspection-ready clinical trial documentation...SeniorLocal area
- ...hrSummary of Position:Looking for an associate or director-level subject matter expert to build clinical operations compliance while upholding our core values and... ...clinical programs, and ensuring programs are inspection ready. Position Responsibilities: Ensure consistency...Work at officeFlexible hours
$200k - $235k
...we serve. We are a clinical-stage company currently... ...experienced team ready to take action... ...The Opportunity The Director, Clinical Operations is a senior member of the Amylyx... ...clinical operations leader with demonstrated success... ...management skills; inspection-ready mind-set....Local areaRemote work$155k - $225k
...suffering from serious diseases.Position Overview:The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership... ...quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and...SeniorFull time- Senior Director, Clinical OperationsCambridge MA, USAAs Senior Director, Clinical Operations, you'll lead operational strategy and execution for one of our programs (either HMB-002 or HMB-003), from early development through pivotal trials.Senior
- Associate Director, Clinical Operations Job Description How you’ll make an impact: Contribute to the planning, implementation, and execution... .... 5 years’ experience leading global clinical trials Inspection readiness experience preferred Experience working on large,...Contract work
$142.5k - $256.5k
## Associate Director, Clinical Operations - OncologyApplylocations: Cambridge,... ...stakeholders such as the Project Leader, Clinical Lead and other... ...decision-making by senior management* Manage invoice... ...on and contribute to inspection readiness activities that support audits...Permanent employmentWork at officeLocal areaWork from home$252k - $283k
...serve. We are a clinical-stage company currently... ...experienced team ready to take action... ...and innovative Senior Director, Clinical Systems... ...join our Clinical Operations organization.... ...thinking clinical leader who enjoys building... ...data integrity, inspection readiness, and applicable...SeniorLocal areaRemote workShift work$177k - $278.08k
...inspire you and empower you to shine? Join us as a Director, Clinical Operations based remotely reporting to the Senior Director, Clinical Operations.At Takeda, we... ...with Strategic Partners.Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs...Minimum wageContract workLocal areaRemote workNight shift- ...goal every day.Reporting to the VP, Clinical Operations, the Director, Clinical Operations is... ...enrollment and study milestones Support inspection readiness and ensure clinical trial activities... ...status, risks, and key milestones to senior leadershipRequirementsBS/BA in...Temporary workWork at officeLocal areaImmediate start3 days per week
$177k - $278.08k
...best of my knowledge.Job DescriptionAbout the role: The Director, PV Clinical Operations provides functional expertise and program-level oversight... ...study- and program-specific audits and regulatory inspections. Drive continuous improvement in the collection, processing...Minimum wageLocal area$219k - $235k
The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences plays a central role in the execution of Phase 1 clinical... ...forecasting, resource planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous...Work at officeLocal areaFlexible hours3 days per week- ...Aditum Bio is seeking a Senior Director, Clinical Operations to lead strategic and operational planning for assigned early-stage clinical development programs across its biotechnology portfolio. Reporting to the SVP, Clinical Development Operations, this role will...Senior
$275k - $285k
...Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual...SeniorFull timeLocal area- ...Director of Clinical Operations ConsultantThe Director, Clinical Operations is responsible for the planning... ..., budget, vendor performance, and inspection readiness. This individual will combine hands... ..., proactive, and collaborative leader with strong judgment, problem-solving...Contract work
- ...Kennedy Bond is partnering with a clinical-stage precision oncology... ...retained search for an Associate Director or Director, Clinical Operations. This individual will join a... ...regulatory submissions, audits, inspections, and inspection readiness activities Requirements: 8+...
$210k - $230k
...inspire performance for life. As the Director, Clinical Research Operations, you will lead the clinical... ...environments. As both a strategic leader and hands-on expert, you will oversee... ..., and Trial Master File inspection readiness.Ensure studies are conducted in accordance...Full timeWork at officeRemote workRelocation$210.4k - $331.1k
...DescriptionRole Summary:The Senior Director, Clinical Science, Genitourinary (... ...with Clinical Operations, Regulatory Affairs, Biostatistics... ...Leads, and cross-functional leaders to support alignment of... ...procedures.Support inspection readiness and appropriate documentation...SeniorFull timeFor contractorsLocal areaFlexible hours$136.6k - $171.9k
...company and culture! Site: Job Description Summary The Senior Manager, Clinical Operations is responsible for the operational planning,... ...policies and standard operating procedures Support inspection readiness and contribute to audit preparations and follow-up activities...SeniorContract workTemporary workWork experience placementWork at office$237k - $290k
...0 / Year Job Category Clinical Operations Employee Type FT Exempt... ...Clinical Operations, the Senior Director, Clinical Operations... ...Operations personnel and emerging leaders Foster a culture of... ...excellence Support inspection readiness, quality initiatives, and...SeniorTemporary workWork at officeLocal areaImmediate startRemote work3 days per week- ...Beeline Medicines is seeking a Senior Director of GCP Quality Assurance to... ...provide strategic leadership and operational oversight of GCP QA activities across clinical development programs. You... ...standards while maintaining inspection readiness and a strong quality culture....Senior
$216.2k - $292.6k
Overview:The Senior Director, Global Environmental Health, Safety and... ...advances regulatory compliance, operational resilience, sustainability... ...3 directly reporting, this leader serves as a trusted advisor... ....Ensure a risk-based, inspection-ready compliance assurance program...SeniorFull timeTemporary workFor contractorsLocal areaFlexible hours$137k - $215.27k
...you to shine? Join us as a Senior Manager, Clinical Trial Delivery and... ...role reporting to the Sr. Director, Clinical Trial Delivery... ...support of study close-out, inspection readiness, acquisitions, divestments... ...maintain physical records room operations, including archiving,...SeniorMinimum wageFull timeLocal area- Clinical Dynamix, Inc. seeks an Associate Director, Clinical Operations to lead and optimize global trials from Watertown, MA. You will plan, execute, and oversee study deliverables, develop study strategies, and mentor CRAs, sites, and vendor teams. Existing expertise...Senior
$210.4k - $331.1k
...Job Description The Senior Director, Clinical Science, Vaccines is responsible... ...with Clinical Operations, Regulatory Affairs, Biostatistics... ..., and cross‑functional leaders to support alignment of... ...established procedures. Support inspection readiness and appropriate...SeniorFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$80k - $150k
...Senior Clinical Data Manager, Clinical Data Management, R&D, Orion Corporation... ...lock and submission readiness. This role plays a critical... ...closely with Clinical Operations, Biostatistics, Statistical... ...Support regulatory submissions, inspection readiness activities,...Senior
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