Director, AI Clinical Operations & Regulatory

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 202,000 - 287,000; Full time

Job summary

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.

Qualifications

• 12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO.
• Experience closing a database lock and supporting at least one FDA regulatory submission.
• Experience with AI-driven pharmacovigilance case processing and signal detection.

Responsibilities

• Lead AI-enabled transformation for trial acceleration, including protocol drafting and EMR-to-CRF integration.
• Own AI for clinical safety operations, including adverse event extraction and signal detection.
• Lead AI-enabled regulatory operations transformation, including submission section drafting and evidence packaging.

Skills

AI-enabled transformation

Regulatory submissions

Clinical development operations

Project leadership

Education

Bachelor's Degree in related discipline

Master’s degree or PhD in a related field

Tools

Medidata Rave

Veeva Vault CTMS

Job description

Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.How you will make an impact:This role will play a pivotal role in leading AI-enabled transformation across Edwards' clinical development and regulatory operations, with initial emphasis on trial acceleration, clinical safety workflows, and submission automation. It does not replace the accountable Clinical Affairs, Safety, Biometrics, or Regulatory functions. It shapes the transformation agenda, co-owns measurable cycle-time and quality outcomes with those leaders, and mobilizes product, data, engineering, and change capabilities to deliver them.Key Responsibilities:Lead AI-enabled transformation for trial acceleration, including protocol and statistical analysis plan drafting, EMR-to-CRF integration, monitoring and alerting, enrollment intelligence, and operating-model redesignOwn AI for clinical safety operations, including adverse event extraction and adjudication, signal detection, and safety committee packet generationLead AI-enabled regulatory operations transformation, including submission section drafting, evidence packaging, review workflows, and adoption controlsValidate and reconcile existing vendor and platform investments across clinical systemsCo-sign cycle-time commitments with Clinical Affairs, Biometrics, and Regulatory leadershipWork with Medical, Clinical & Regulatory teams for protocol and trial designOther incidental dutiesWhat you'll need (Required):Bachelor's Degree in related discipline, with 12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CRO -OR- Master’s, PhD, or other advanced degree with 10 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or equivalent leadership at a clinical technology vendor or CROA record of redesigning clinical or regulatory workflows and achieving measurable adoption, cycle-time, quality, or productivity improvementsDirect, personal experience closing a database lock and supporting at least one FDA regulatory submissionExperience with AI-driven pharmacovigilance case processing and signal detection, gained at a biopharma company, CRO, or safety-technology vendor: this discipline is materially more mature in biopharma than in medtech, and that experience transfers directly What else we look for (Preferred):Other: Certification in related fieldBuilding and defending a benefits case under Finance-level scrutinyNegotiating and co-signing commitments directly with senior Clinical Affairs and Regulatory leadership across multiple therapy areasWorking fluency with major CTMS and clinical data platforms (Medidata Rave, Veeva Vault CTMS, or equivalent) and Good Clinical Practice (GCP) requirementsFamiliarity with natural-language and document-automation tooling applied to protocols, statistical analysis plans, or safety narrativesDirect exposure to AI-enabled pharmacovigilance platforms (Oracle Argus Safety, ArisGlobal LifeSphere, or Veeva Vault Safety) and their AI-driven case intake, MedDRA coding, and signal-scoring capabilitiesFamiliarity with AI-driven patient recruitment and site-selection approaches from biopharma trial operations: NLP-based EHR mining for eligibility screening, digital biomarkers and wearable data for continuous safety monitoring, and in silico trial simulation for protocol feasibility testingWorking knowledge of ICH E6(R3) and its implications for AI-assisted trial oversightExperience standing up or consolidating clinical AI tooling across a multi-therapy-unit organizationFamiliarity with major clinical data platforms such as Medidata or VeevaDirect biopharma clinical operations experience, where AI adoption in trial acceleration and safety operations is further along than in medtechAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California (CA), the base pay range for this position is $202,000 to $287,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.