Director, AI Clinical Operations & Regulatory

Regulatory Toolkit; Irvine (CA); On-site; USD 202,000 - 287,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking a leader to drive AI-enabled transformation across clinical development and regulatory operations in California. You will shape trial acceleration, safety workflows, and submission automation, collaborating with Medical, Clinical & Regulatory teams.

This senior role demands deep experience in regulatory submissions, AI tooling, and cross-functional leadership. The role interfaces with CTMS and clinical data platforms, including Medidata Rave and Veeva Vault, to

Qualifications

• Bachelor’s degree in a related discipline with 12 years of experience in clinical development operations, data management, biometrics, or regulatory operations, or a Master’s/PhD with 10 years in the same areas
• Proven record redesigning workflows and achieving measurable adoption, cycle-time, quality, or productivity improvements
• Direct experience closing a database lock and supporting at least one FDA regulatory submission
• Experience with AI-driven pharmacovigilance and safety tooling in biopharma or CRO environments

Responsibilities

• Lead AI-enabled transformation for trial acceleration and protocol design
• Own AI for clinical safety operations including adverse event extraction and safety package generation
• Lead AI-enabled regulatory operations transformation including submission drafting and evidence packaging
• Validate and reconcile vendor investments across clinical systems
• Co-sign cycle-time commitments with Clinical Affairs, Biometrics, and Regulatory leadership

Skills

AI transformation leadership

Clinical development operations

Regulatory operations leadership

Data management

FDA submissions

Education

Bachelor's degree + 12 years experience

Master’s/PhD + 10 years experience

Tools

Medidata Rave

Veeva Vault CTMS

Oracle Argus Safety

ArisGlobal LifeSphere

Veeva Vault Safety

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 redesign

• Own AI for clinical safety operations, including adverse event extraction and adjudication, signal detection, and safety committee packet generation

• Lead AI-enabled regulatory operations transformation, including submission section drafting, evidence packaging, review workflows, and adoption controls

• Validate and reconcile existing vendor and platform investments across clinical systems

• Co-sign cycle-time commitments with Clinical Affairs, Biometrics, and Regulatory leadership

• Work with Medical, Clinical & Regulatory teams for protocol and trial design

• Other incidental duties

What 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 CRO

• A record of redesigning clinical or regulatory workflows and achieving measurable adoption, cycle-time, quality, or productivity improvements

• Direct, personal experience closing a database lock and supporting at least one FDA regulatory submission

• Experience 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 field

• Building and defending a benefits case under Finance-level scrutiny

• Negotiating and co-signing commitments directly with senior Clinical Affairs and Regulatory leadership across multiple therapy areas

• Working fluency with major CTMS and clinical data platforms (Medidata Rave, Veeva Vault CTMS, or equivalent) and Good Clinical Practice (GCP) requirements

• Familiarity with natural-language and document-automation tooling applied to protocols, statistical analysis plans, or safety narratives

• Direct 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 capabilities

• Familiarity 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 testing

• Working knowledge of ICH E6(R3) and its implications for AI-assisted trial oversight

• Experience standing up or consolidating clinical AI tooling across a multi-therapy-unit organization

• Familiarity with major clinical data platforms such as Medidata or Veeva

• Direct biopharma clinical operations experience, where AI adoption in trial acceleration and safety operations is further along than in medtech

• Adhere 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/control

Aligning 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.