Kardigan is seeking a Sr. Manager, Clinical Trial Lead to manage one of its cardiovascular clinical studies. As a Clinical Trial Lead (CTL), you will be part of the Clinical Operations team reporting to the asset's Clinical Operations Program Leader (COPL). 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. This role is for a regional CTL. As a 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. This position is 4-day onsite position in Princeton, NJ. (May consider onsite in South San Francisco) Key Responsibilities: Trial Leadership & Oversight • Lead the planning, execution, and delivery of assigned clinical trials (global or regional scope). • Drive study timelines, milestones, and deliverables from synopsis through Clinical Study Report. • Serve as the primary operational point of contact for the cross-functional study team. • Align team execution with the study's regulatory submission strategy and overall development plan. Study Start-Up & Execution • Oversee site feasibility, selection, initiation, and activation; delegate to Clinical Trial Managers (CTMs) as appropriate. • Partner with CTMs to ensure vendor and site readiness across start-up, enrollment, monitoring, and closeout. • In partnership with the COPL, develop and execute participant recruitment strategies; review and approve operational plans, study manuals, and charters. • Lead operational strategy related to drug supply, remote monitoring, and decentralized trial processes. • Collaborate closely with the Clinical Development Lead on protocol development, amendments, and master ICFs. • Liaise with cross-functional team representatives to ensure cohesive trial execution. Vendor Management • Provide input into CRO and vendor selection, ensuring alignment with trial needs and operational strategy. • Direct and manage CRO and vendor partnerships, holding them accountable for timelines, quality, and budget commitments. • Drive management of CROs, vendors, and external partners through oversight, escalation, and proactive issue resolution. Budget & Resource Management • Contribute to initial trial budget development and ongoing financial oversight. • Review and approve CRO/vendor work orders and change orders for accuracy and completeness. Quality, Compliance & Risk Management • Ensure compliance with ICH-GCP, local regulations, and company SOPs. • Oversee and coordinate the review of protocol deviations; manage amendments with cross-functional alignment. • Partner with Data Management to develop and approve data cleaning plans. • Maintain decision, action, and risk logs; escalate issues proactively and implement CAPAs when required. • Contribute to inspection readiness and support audits and regulatory inspections. Reporting & Documentation • Coordinate responses to health authorities, ethics committees, and IRBs as needed. • Review and contribute to clinical study reports and regulatory filings. People Management • May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g. contingent workers). • Provide coaching, feedback, and performance management to direct reports. • Support career development and training to build functional and leadership capabilities within the team. • Lead by example, fostering a collaborative and high-performance culture. Here's What You'll Bring to the Table: • Minimum of BA/BS with approximately 8+ 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 required. • 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 • Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence. • Confidence to challenge status-quo thinking and behavior • Can work with agility and an innovative mindset. • Experience in ICH/GCP inspections, audits and inspection preparedness • Experience in mentoring Clinical Operations staff Exact Compensation may vary based on skills, experience and location. Pay range $166,000-$216,000 USD