Director, AI Clinical Operations & Regulatory

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.