Senior Director, IDE Clinical Trials – Cardio Device

Supira Medical; United States; On-site; USD 200,000 - 230,000; Full time

Job summary

Supira Medical in the United States is seeking a Senior Director, Clinical Affairs to own the IDE pivotal trial from activation to database lock, ensuring budget, timeline, data integrity, and regulatory compliance. The leader partners with R&D, Regulatory, Quality, and Marketing and manages CROs, sites, and KOLs.

The role requires extensive FDA/ISO knowledge, senior-level trial management, and the ability to travel ~50% to clinical sites and meetings.

Qualifications

• 15+ years in clinical research/clinical affairs in medical devices.
• 10+ years in a leadership role managing trial programs.
• Direct IDE pivotal trial experience in cardiovascular or related devices.
• Deep knowledge of FDA rules (21 CFR Parts 812, 50, 56), GCP/ICH E6, ISO 14155.
• Experience managing CROs, core labs, DSMBs, CECs, and FDA interactions.
• Proven ability to lead budgets, timelines, and cross-functional teams.
• Excellent written and verbal communication with executives.
• Willingness to travel ~50% to clinical sites and meetings.

Responsibilities

• Own end-to-end IDE pivotal trial execution (sites, enrollment, monitoring, data).
• Finalize/amend protocol, study charters, SAP, and consent documents.
• Oversee site management, activation, and investigator relationships.
• Select and manage CROs/vendor partners; ensure scope and quality.
• Cultivate relationships with KOLs and trial steering committee.
• Ensure regulatory compliance with FDA & ISO requirements.
• Own trial timeline; provide status updates and risk mitigations.
• Oversee data management and audit readiness with Biostatistics.
• Support IDE, PMA modules, and FDA interactions for submissions.
• Build and mentor Clinical Affairs team as the trial scales.

Skills

Clinical trial leadership

FDA/ISO regulatory knowledge

Budget management

Cross-functional leadership

Team mentoring

Executive communication

Travel willingness (~50%)

Education

Bachelor's degree in life sciences

Advanced degree (MS/PhD/RN or equivalent)

Tools

CRO oversight

Regulatory submission processes

Job description

Supira Medical in the United States is seeking a Senior Director, Clinical Affairs to own the IDE pivotal trial from activation to database lock, ensuring budget, timeline, data integrity, and regulatory compliance. The leader partners with R&D, Regulatory, Quality, and Marketing and manages CROs, sites, and KOLs.

The role requires extensive FDA/ISO knowledge, senior-level trial management, and the ability to travel ~50% to clinical sites and meetings.