Sr. Manager, Clinical Trial Lead

Regulatory Toolkit; Princeton (NJ); On-site; USD 166,000 - 216,000; Full time

Job summary

Kardigan in Princeton, NJ is seeking a Sr. Manager, Clinical Trial Lead to manage regional cardiovascular studies. You will lead trial leadership, start-up, vendor management, and budgets within a global program, reporting to the Clinical Operations Program Leader.

This role requires BA/BS with 8+ years in global CLTR management; cardiovascular study experience is desirable. The position is 4-day onsite in Princeton with potential onsite in South San Francisco.

Qualifications

• Minimum of BA/BS with approximately 8+ years of experience in global clinical trial management roles. Advanced degree preferred.
• Experience within 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, protocol deviations, and data cleaning.
• Excellent communication skills, both verbal and written.
• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence.
• Experience in ICH/GCP inspections, audits and inspection preparedness.
• Experience in mentoring Clinical Operations staff.

Responsibilities

• 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.
• Oversee site feasibility, selection, initiation, and activation; delegate to Clinical Trial Managers as appropriate.
• Partner with CTMs to ensure vendor and site readiness across start-up, enrollment, monitoring, and closeout.
• 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.
• Liaise with cross-functional team representatives to ensure cohesive trial execution.
• 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.
• Contribute to initial trial budget development and ongoing financial oversight.
• Review and approve CRO/vendor work orders and change orders for accuracy and completeness.
• 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; elevate issues proactively and implement CAPAs when required.
• Contribute to inspection readiness and support audits and regulatory inspections.
• Coordinate responses to health authorities, ethics committees, and IRBs as needed.
• Review and contribute to clinical study reports and regulatory filings.
• May directly manage Clinical Trial Associates, Clinical Trial Managers, or other assigned staff; provide coaching, feedback, and performance management.

Skills

Trial leadership

Cross-functional leadership

Communication skills

Budget management

Regulatory compliance

Education

BA/BS in a related field

Advanced degree preferred

Job description

About Us

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.

It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.

Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.

We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.

These values are the foundation of our work, empowering us to make a real difference, every day.

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; elevate 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