Director, Clinical Quality Lead
Drive GxP QA across R&D, leading audits, CAPAs, and regulatory readiness for GCP/GLP/GVP.
- Remote
- Full Time
- $194,000 – $253,000/year
- Min. 15 YOE
Browse the full live job inventory for Kardigan. This page is focused on current openings, while the overview tab highlights role groups and hiring patterns.
Drive GxP QA across R&D, leading audits, CAPAs, and regulatory readiness for GCP/GLP/GVP.
Director leads regional CTL activities to support site feasibility, patient recruitment, and CRO collaboration across Northern Midwest.
Executive leadership shaping enterprise data, AI and collaboration strategy across R&D, G&A, and Commercial.
Leads global site management and monitoring to accelerate trial timelines and optimize enrollment with strategic partnerships.
Senior leader overseeing Quality Control/QA for clinical-stage small molecule substances, with data review, stability, and change control.
Lead clinical strategy and execution for Tonlamarsen program, coordinating cross-functional teams to drive late-stage development.
Lead region-wide trial site recruitment and feasibility activities for cardiovascular studies with extensive travel.
Senior Director leads end-to-end CMC drug substance development, overseeing small molecules and oligonucleotides from route design to commercial readiness.
Senior legal leader guiding complex clinical development contracts and commercial transactions for a biotech.
Lead enterprise strategy development and execution, shaping priorities across growth, modalities, and cross-functional partnerships.
Director leads enterprise CSA/CSV framework across GxP environments, ensuring data integrity and DHT compliance to support regulatory inspections.
Leads digital innovation, AI-enabled HEOR initiatives and evidence generation across Medical Affairs with Prolaio integration.
Strategic legal leader drafting and negotiating complex contracts to optimize business outcomes across life sciences partnerships.
Executive leadership role driving data-driven portfolio strategy, NPVs, and cross-functional governance.
Senior-level accounting role focused on GAAP-compliant financial operations, payroll, AP, and system integration.
Leads Prolaio strategy, pricing, partnerships, and cross-functional initiatives to accelerate growth and clinical research outcomes.
Leads external manufacturing strategy and CDMO partnerships to ensure compliant API/DP supply for late-stage programs.
Strategic People & Culture partner advising senior leaders on workforce strategies, organizational design, and culture initiatives.
Leads end-to-end business analysis for Development & Quality in a GxP-regulated drug development environment.
Lead IT Business Partner framework for Medical & Commercial, aligning IT with regulated biopharma needs and enabling AI/data capabilities.
Leads statistical programming activities, SDTM/ADaM, and CRO management to deliver regulatory-ready analyses.
Scientific leader advancing regional cardiovascular medical strategy and KOL partnerships.
Leads national field medical strategy and teams to improve patient care through scientific leadership and collaboration across Global Program Teams.
Lead regional clinical trials delivery, ensuring timelines, budgets, and quality under ICH-GCP across cardiovascular studies.