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$166k–$216k/yr
Full-time
bachelor degree, postgraduate degree
Posted 60d ago
~40 hrs/week
Responsibilities
Lead the planning, execution, and delivery of cardiovascular clinical trials while managing CRO and vendor partnerships. Ensure all project deliverables meet budget, timeline, and quality standards in compliance with ICH-GCP and regulatory requirements.
Requirements
Requires a BA/BS with at least 8 years of experience in global clinical trial management, with a preference for advanced degrees and cardiovascular or rare disease expertise. Must have experience in both early and late-phase drug development and a proven track record of leading cross-functional teams.
Full 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; 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.
Cardiovascular disease is the leading cause of death in the world.
We are developing novel medicines to change that.
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2023
Headquarters
Princeton, New Jersey
LinkedIn followers
9,147
Total funding
$554M
Kardigan is a patient-driven heart health company that is modernizing cardiovascular drug development to deliver medicines that move patients beyond symptom management to functional cures. By matching critical disease drivers with treatment responders identified in clinical trials, Kardigan is developing a portfolio of medicines that modify the underlying cardiovascular disease pathophysiology to get patients closer to the cures they deserve. Kardigan has significant East and West Coast operations and focus.
For more information about Kardigan, please visit kardigan.bio. If you are interested in joining our passionate and driven team with deep cardiovascular, biotechnology and operational expertise, please visit kardigan.bio or the careers tab of this page.
Offices: Princeton, New Jersey, US · South San Francisco, California, US
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How much do Management & Leadership jobs in Princeton, NJ pay?
Based on 439 listings with disclosed salaries, most management & leadership jobs in Princeton, NJ pay between $95k–$239k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Princeton, NJ right now?
There are currently 507 open management & leadership positions in Princeton, NJ listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Princeton, NJ?
Companies currently hiring include Bristol Myers Squibb, Otsuka Pharmaceutical Companies (U.S.), Princeton University Strategic Partnerships and Engagement, Kardigan, Integra LifeSciences, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Princeton, NJ?
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