Associate Director, Clinical Trial Lead bei Kardigan

Kardigan is seeking an Associate Director, Clinical Trial Lead (CTL) to manage its cardiovascular clinical studies. As a CTL, you will be part of the Clinical Operations team reporting to the asset’s Clinical Operations Program Leader (COPL). The CTL is accountable for the operational delivery of the assigned clinical trial, serving as the primary operational contact and leader for the cross-functional study execution team. The CTL may lead trials at a global level (overseeing multi-regional execution) or at a regional level (driving operational delivery in assigned countries/territories), depending on business needs. As a global or regional CTL, you will ensure that key project deliverables are met according to the budget and timelines and quality standards (as defined by regulations, SOPs, and ICH-GCP) with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Kardigan is a 4 -day onsite company (M - Th)

Key Responsibilities:

• Lead the planning, execution, and delivery of assigned clinical trials (global or regional), ensuring alignment with regulatory submission strategy and development plans.
• Serve as the primary operational contact for cross-functional teams, CROs, vendors, and sites; provide input into partner selection and oversee performance against timelines, quality, and budget.
• Oversee site, CRO and vendor readiness across feasibility, start-up, enrollment, monitoring, and closeout, delegating and partnering with Clinical Trial Managers and Associates as appropriate.
• Drive recruitment strategies, operational plans, and execution of innovative trial processes (e.g., drug supply, remote monitoring, decentralized approaches).
• Ensure trial compliance with ICH-GCP, SOPs, and regulations; proactively manage risks, protocol deviations, CAPAs, and inspection readiness.
• Contribute to budget oversight, work order/change order reviews, and ongoing financial management.
• Review and approve key trial documentation, including protocols, amendments, ICFs, operational manuals, regulatory responses, and clinical study report
• May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g. contingent workers).
• Lead by example, fostering a collaborative and high-performance culture.

Requirements:

• Minimum of BA/BS with approximately 10 years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs. Advanced degree preferred.
• Experience within the field of cardiovascular studies and/or rare disease is desirable.

• Experience in early and late phase drug development; some late-stage development experience is preferred.
• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
• Excellent communication skills, both verbal and written
• Travel to conferences, meetings, clinical trials sites and Kardigan locations required ~30% time
• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence.

• Can work with agility and an innovative mindset.

• Experience in ICH/GCP inspections, audits and inspection preparedness