Kardigan, Inc.
Associate Director, Clinical Trial Lead
Kardigan, Inc., San Francisco, California, United States, 94199
Overview
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. Position
Kardigan is seeking an Associate Director, Clinical Trial Lead (CTL) to manage its cardiovascular clinical studies. As a CTL, you will be part of the Clinical Operations team reporting to the asset’s Clinical Operations Program Leader (COPL). The CTL is accountable for the operational delivery of the assigned clinical trial, serving as the primary operational contact and leader for the cross-functional study execution team. 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. As a global or 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 onsite company (M - Th) Responsibilities
Lead the planning, execution, and delivery of assigned clinical trials (global or regional), ensuring alignment with regulatory submission strategy and development plans. Serve as the primary operational contact for cross-functional teams, CROs, vendors, and sites; provide input into partner selection and oversee performance against timelines, quality, and budget. Oversee site, CRO and vendor readiness across feasibility, start-up, enrollment, monitoring, and closeout, delegating and partnering with Clinical Trial Managers and Associates as appropriate. Drive recruitment strategies, operational plans, and execution of innovative trial processes (e.g., drug supply, remote monitoring, decentralized approaches). Ensure trial compliance with ICH-GCP, SOPs, and regulations; proactively manage risks, protocol deviations, CAPAs, and inspection readiness. Contribute to budget oversight, work order/change order reviews, and ongoing financial management. Review and approve key trial documentation, including protocols, amendments, ICFs, operational manuals, regulatory responses, and clinical study reports. May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g., contingent workers). Lead by example, fostering a collaborative and high-performance culture. Qualifications
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 preferred. 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. Travel to conferences, meetings, clinical trials sites and Kardigan locations required ~30% time. Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence. Can work with agility and an innovative mindset. Experience in ICH/GCP inspections, audits and inspection preparedness. Additional information
This role requires working with regulatory standards and may involve remote or onsite responsibilities as applicable. Kardigan is an equal opportunity employer and supports diversity in all its hiring decisions. Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary. Any information you provide will be confidential and will not be used in hiring decisions. Kardigan’s Equal Employment Opportunity policy notes that we do not discriminate on the basis of protected status. If you belong to any protected veteran or disability categories, please indicate as appropriate. See also the voluntary disability sections below for additional context. Disability status (voluntary): The following categories are provided for reporting as part of EEO compliance and do not affect hiring decisions. 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. Examples include but are not limited to the following: cardiovascular or heart disease; cancer; autoimmune disorders; mental health conditions; mobility impairments; and other listed conditions. Public burden statement: This survey is part of EEO compliance and does not affect hiring decisions. The form provides voluntary information for reporting under applicable laws and regulations.
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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. Position
Kardigan is seeking an Associate Director, Clinical Trial Lead (CTL) to manage its cardiovascular clinical studies. As a CTL, you will be part of the Clinical Operations team reporting to the asset’s Clinical Operations Program Leader (COPL). The CTL is accountable for the operational delivery of the assigned clinical trial, serving as the primary operational contact and leader for the cross-functional study execution team. 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. As a global or 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 onsite company (M - Th) Responsibilities
Lead the planning, execution, and delivery of assigned clinical trials (global or regional), ensuring alignment with regulatory submission strategy and development plans. Serve as the primary operational contact for cross-functional teams, CROs, vendors, and sites; provide input into partner selection and oversee performance against timelines, quality, and budget. Oversee site, CRO and vendor readiness across feasibility, start-up, enrollment, monitoring, and closeout, delegating and partnering with Clinical Trial Managers and Associates as appropriate. Drive recruitment strategies, operational plans, and execution of innovative trial processes (e.g., drug supply, remote monitoring, decentralized approaches). Ensure trial compliance with ICH-GCP, SOPs, and regulations; proactively manage risks, protocol deviations, CAPAs, and inspection readiness. Contribute to budget oversight, work order/change order reviews, and ongoing financial management. Review and approve key trial documentation, including protocols, amendments, ICFs, operational manuals, regulatory responses, and clinical study reports. May directly manage Clinical Trial Associates (CTAs), Clinical Trial Managers (CTMs), or other assigned staff (e.g., contingent workers). Lead by example, fostering a collaborative and high-performance culture. Qualifications
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 preferred. 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. Travel to conferences, meetings, clinical trials sites and Kardigan locations required ~30% time. Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence. Can work with agility and an innovative mindset. Experience in ICH/GCP inspections, audits and inspection preparedness. Additional information
This role requires working with regulatory standards and may involve remote or onsite responsibilities as applicable. Kardigan is an equal opportunity employer and supports diversity in all its hiring decisions. Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary. Any information you provide will be confidential and will not be used in hiring decisions. Kardigan’s Equal Employment Opportunity policy notes that we do not discriminate on the basis of protected status. If you belong to any protected veteran or disability categories, please indicate as appropriate. See also the voluntary disability sections below for additional context. Disability status (voluntary): The following categories are provided for reporting as part of EEO compliance and do not affect hiring decisions. 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. Examples include but are not limited to the following: cardiovascular or heart disease; cancer; autoimmune disorders; mental health conditions; mobility impairments; and other listed conditions. Public burden statement: This survey is part of EEO compliance and does not affect hiring decisions. The form provides voluntary information for reporting under applicable laws and regulations.
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