Sr. Manager, Clinical Trial Lead - South San Francisco or Princeton, NJ

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. OR South San Francisco CA

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 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; late-stage (Phase 2/3) 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.