Director, AI-Driven Clinical Ops & Regulatory
Jobleads-US
Edwards Lifesciences Gruppe seeks a senior leader to drive AI-enabled transformation across clinical development operations, regulatory workflows, and safety monitoring. You will partner with Medical, Clinical & Regulatory teams to redesign processes for faster, safer outcomes.
This role requires extensive experience with FDA submissions, protocol design, and leveraging NLP/AI tools to accelerate trials and automate safety reporting in a regulated environment.
#J-18808-Ljbffr Jobleads-US- ...system designed to maximize clinical flexibility and ease-of-... .... The Associate Director of Software, Digital Health... ...: Patient-Centric, Driven, Accountable, and Collaborative... ...applications, and AI solutions. Ensure compliance with regulatory standards (e.g., FDA, HIPAA...Regulatory
- ...Purpose statement Own and evolve the clinical process engineering capability within Clinical... ...across the enterprise. The Associate Director, Clinical Process Engineer is the... ...manage risk and partner with quality and regulatory leadership on emerging expectations. #...RegulatoryLocal area
$202k - $287k
...Our Advanced Innovation & Technology (AI&T) teams harness the imagination,... ...enabled transformation across Edwards' clinical development and regulatory operations, with initial emphasis on... ...regulatory submissionExperience with AI-driven pharmacovigilance case processing and...Regulatory$202k - $287k
...Edwards Lifesciences seeks a Director to lead AI-driven transformation across clinical development and regulatory operations. The role focuses on trial acceleration, clinical safety workflows, and submission automation while collaborating with existing Clinical Affairs...Regulatory$110.1k - $183.4k
...Flexibility: Remote Stryker is hiring an Clinical Research Data Associate Manager in our... ...delivery of high-quality reliable and regulatory-compliant clinical data. The Associate... ...regulatory submissions and data-driven decision making. Support database validation...RegulatoryFull timeFor contractorsInterim roleRemote work$121.5k - $151.9k
...quantitative and analytical skills for data-driven decision-making. Ability to thrive in a... ...with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v)... ...of such jurisdictions. How We Use AI in Our Hiring Process: To ensure transparency...RegulatoryFull timeContract workTemporary workPart timeLocal areaImmediate startShift work$129k - $179k
...of systems is powered by Lattice OS, an AI-powered operating system that turns thousands... ..., generate reports, and provide data-driven insights to support decision-making and optimize... ...processes. Ensure compliance with regulatory requirements, safety standards, and quality...RegulatoryFull timeWork experience placementLocal area$188.2k - $263.6k
About the RoleAs Director, Translational Science/Pharmacokinetics... ...nonclinical development, clinical development, and regulatory strategy, you'll generate... ...and bring in new methods, AI technologies, and external... ...-team learning.Outcome Driven - Demonstrates strong outcomes...RegulatoryWork at officeLocal areaRemote work$188.2k - $263.6k
About the RoleThe Director, Pharmacology will be a scientific and strategic... ...connects the discovery and clinical development organizations and... ...cross-team learning.Outcome Driven - Demonstrates strong... ...and translational sections of regulatory documents (IND, Investigator'...RegulatoryWork at officeLocal areaRemote work$188.2k - $263.6k
...About the RoleThe Director, Toxicology Translational Science will... ...science to bridge discovery and clinical development from concept... ...rigor, data integrity, and regulatory compliance (GLP, animal welfare... ...and implement innovative AI driven toxicology approaches including...RegulatoryWork at officeLocal areaRemote work$203.2k - $284.6k
...Director, Alliance Management Irvine, California, United States Reporting to the... ...together subject-matter experts (Clinical, Regulatory, Translational Science, CMC/manufacturing... ...effectiveness and cross-team learning. Outcome Driven - Demonstrates strong outcomes focus...RegulatoryWork at officeImmediate start$150k - $210k
...experienced and visionary Associate Director of Innovation Lab to drive... ...from ideation stage and pre-clinical proof of concept to... ...of action, PK/PD, clinical, regulatory, and commercial success considerations... ...Puts the team first.Outcome Driven - Clearly defines mutual expectations...RegulatoryWork at officeLocal areaRemote work- ...Edwards Lifesciences in Irvine, CA is seeking an experienced AI/ML Product Manager to lead regulatory-compliant product initiatives in structural heart technology. You will own AI-enabled features, define the portfolio strategy, and build the business case to drive adoption...Regulatory
- ...Associate Director leading clinical process engineering strategy and capability development within Clinical Development Operations. Responsible... ...Deep expertise in clinical development operations, regulatory frameworks, and inspection readiness Expert proficiency...Regulatory
$137k - $235.75k
...and knowledgeable Associate Director - Medical Science Liaison (MSL... ...business acumen and Med Affairs/Clinical Affairs background. Key... ...clinical research methodologies, regulatory guidelines, and medical... ...Collaboration, Customer Centricity, Data‑Driven Decision Making, Data...RegulatoryWork at officeLocal areaImmediate startRelocationFlexible hours$166k - $220k
Associate Director, Business Development, Critical Infrastructure Defense... ...is powered by Lattice OS, an AI-powered operating system that... ...country. We're looking for a driven Associate Director of Business... ..., operational requirements, regulatory environment, and competitive landscape...RegulatoryFull timeWork experience placementLocal areaWorldwide$150k - $210k
Associate Director, Chemical DevelopmentAbout the RoleThe Associate... ...Analytical Development, Quality, Regulatory Science, and Supply Chain to... ...the continuous supply of clinical and commercial products.Let’s... ...Puts the team first.Outcome Driven - Clearly defines mutual expectations...RegulatoryWork at officeLocal areaRemote work- ...-00049 Responsibilities: Lead and manage clinical data management activities for oncology clinical... ...in alignment with study protocols and regulatory requirements. Oversee the design, build,... ...clinical data collection and management (e.g., ePRO, wearables, AI/ML applications)RegulatoryWork at office
$160k - $190k
...months of hire).Up to date on the latest advances in technology, regulatory trends, equipment, and processes. Ability to support and/or lead... ...eligible for referral fees.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing...RegulatoryHourly payFull timeWork at officeLocal area1 day per week$141.5k - $268.5k
...Associate Director, Customer Engagement and Injector Training Full... ...development of compliant, insight-driven education and training experiences that strengthen clinical confidence, elevate customer... ...marketing, sales, medical, regulatory, legal, compliance, operations...RegulatoryFull time$191k - $253k
...sold. Anduril’s family of systems is powered by Lattice OS, an AI-powered operating system that turns thousands of data streams into... ...export control teams to ensure all solutions strictly adhere to regulatory and export control requirements. Drive disciplined...RegulatoryFull timeFor contractorsWork experience placementWork at officeWorldwide- ...creativity and execution. Job DescriptionThe Director, Oligo & Peptide Market Segment Leader... ...of Life Sciences, POR and Regional Ops to drive technical excellence consistency... ...C reviewer network. Growing CRB’s market regulatory expertise. Being the market face of CRB for...Regulatory
- ...future is uncharted. By combining our expertise across connectivity, AI, security and more, we’ll map a new way forward. Working... ...an employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) record keeping; (vi) ensuring...RegulatoryFull timeContract work
$129k - $171k
...is powered by Lattice OS, an AI-powered operating system that... ...years.ABOUT THE JOB The Associate Director, Kitchen Operations - West... ...portfolio is expected. We are driven by our outcomes here at Anduril... ...strong food safety, sanitation, regulatory compliance, and risk...RegulatoryFull timeContract workWork experience placementImmediate start- ...Instagram , X and YouTube. Job Description The Associate Director, Clinical Development will have regional and/or global... ...on strong scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations...RegulatoryFull timeWork at officeLocal area
- ...'ll Join We are a mission driven community-based organization... ...security, and the Executive Directors who oversee these areas. Together... ...bodies. What the Regulatory Agencies Need You to Possess?... ...Work is typically indoors in a clinical setting serving the frail and...RegulatoryTemporary workWork at officeLocal areaRemote workFlexible hoursWeekend workAfternoon shift
- ...Opportunity We are a mission driven community-based organization... ...security, and the Executive Directors who oversee these areas.... ...legislative bodies. What the Regulatory Agencies Need You to Possess?... ...Work is typically indoors in a clinical setting serving the frail and...RegulatoryTemporary workWork at officeLocal areaRemote workFlexible hoursWeekend workAfternoon shift
$168k - $209k
...realistically, and deliver software, data, AI, and technology capabilities with greater... ...execution, release, and maintenance. The Director, Technical Program Management & Delivery... ..., strategic alignment, risk reduction, regulatory or operational need, effort, dependencies...Regulatory$255k - $357k
...The Senior Director, Technical Operations provides strategic leadership and oversight of... ..., Analytical Development, Supply Chain, Regulatory and Quality. Let’s talk about some of... ...manufacturing strategy from late phase clinical through commercial stages. Ensure scalability...RegulatoryWork at officeLocal areaRemote work- ...Clinical Research Associate II Join the forefront of groundbreaking research at the Beckman... ...and compassionate faculty and staff are driven by a common mission: Contribute to... ...research protocols with a focus on efficiency, regulatory compliance, and study oversight. In this...RegulatoryHourly payWork experience placementShift work
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