Kardigan
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 Giannakakos, Jay Edelberg, M.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.
Kardigan is a 4-day on-site company Mon - Thurs
Key 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.
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.
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 10 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
$157,000 - $205,000 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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential 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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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.
Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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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 Giannakakos, Jay Edelberg, M.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.
Kardigan is a 4-day on-site company Mon - Thurs
Key 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.
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.
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 10 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
$157,000 - $205,000 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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential 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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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.
Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr