Senior Director, Clinical Operations Program Lead

Kardigan; Princeton (NJ); On-site; USD 247,000 - 322,000; Full time

Job summary

Kardigan, a heart health company, seeks a Senior Director, Clinical Operations Program Lead in Princeton, NJ, to lead all activities for a late-stage cardiovascular asset across phases. Reports to Head of Development Operations and collaborates with cross-functional teams to meet study objectives.

Responsibilities include budget and timeline delivery, vendor oversight, and strategic operational plans spanning feasibility, site activation, enrollment, and data management within ICH/GCP guidelines.

Qualifications

• Global clinical trial and program experience, 12+ years.
• 6+ years in high complexity global trial management.
• Cardiovascular or rare disease study experience preferred.

Responsibilities

• Lead delivery of program budget, timelines and resources.
• Oversee CROs, vendors and external partnerships.
• Represent Clinical Operations in cross-functional meetings.
• Ensure compliance with ICH/GCP and Kardigan SOPs.

Skills

Clinical operations leadership

Cross-functional collaboration

Leadership and team-building

ICH/GCP inspections

Vendor/CRO management

Education

BA/BS in related field

Advanced degree preferred

Job description

Senior Director, Clinical Operations Program Lead

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.

Position Title: Sr. Director Clinical Operations Program Lead

Department: Development

Reports To: Head of Clinical Development

Location: Princeton, New Jersey - 4 days on site (Mon-Thur)

Job Overview

Kardigan is seeking a Senior Director, Clinical Operations Program Lead for a late-stage cardiovascular asset. This position will be responsible for leading all of the activities associated with the clinical studies for the asset across all phases, including overseeing the internal operations team, CROs and vendors and working cross-functionally on the operational strategy and related initiatives. This position reports to the Head of Development Operations and serves as a member of the Development Operations Leadership team. This position will work collaboratively across the department, the entire Kardigan portfolio and cross-functionalcore/project teams with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Essential Duties and Responsibilities:

• Accountable for the delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop and present the operational strategy and plans including supply chain to effectively execute on the Clinical Development Plan
• Partner and collaborate with cross-functional stakeholders such as the Project Team Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders
• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Kardigan’s SOPs
• Drive the selection, oversight, and management of CROs and other vendors
• Oversee site feasibility/capability assessments in collaboration with the CRO and crossfunctional team
• Own the strategy and execution of creative approaches to achieve Kardigan’s corporate goals. This may include innovative solutions to digital patient-oriented data capture and storage, the development and deployment of novel clinical research platforms and approaches, and the pursuit of collaborations that will enhance progress of Kardigan’sresearch programs
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Lead and provide oversight to the trial-specific operations team including the CROs/vendor(s) to function effectively and cohesively
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
• Along with other Clinical Development personnel, represent Kardigan’s externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in Development Operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Kardigan’s, including Prolaio
• Directly manage assigned Clinical Trial Leads with a focus on performance, coaching and career development; provide mentorship to Site Operations Managers/Associates by providing clinical operations expertise and support identification and prioritization of study and program level work.
• Strive for continuous improvement and more efficient ways of working in clinical development

Qualifications and Preferred Skills

• Minimum of BA/BS with at least 12 years of global clinical trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience. Advanced degree preferred.
• Experience within the field of cardiovascular or rare disease studies is preferred.
• Robust 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.
• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
• Experience in ICH/GCP inspections, audits and inspection preparedness
• Outstanding communication skills, both verbal and written
• Excellent organizational skills and ability to work independently
• Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset.

Exact Compensation may vary based on skills, experience and location.

Pay range

$247,000 - $322,000 USD

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Kardigan’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.