Kardigan
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. Kardigan’s mission is 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. Core values:
Driven by patients and their families ;
Authentic ;
Eagerness to learn ;
Winning as a team ;
Enabling the impossible . 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‑Thu) Job Overview
Kardigan is seeking a Senior Director, Clinical Operations Program Lead for a late‑stage cardiovascular asset. This role will lead all activities associated with the clinical studies, including overseeing the internal operations team, CROs and vendors, and working cross‑functionally on the operational strategy and related initiatives. The position reports to the Head of Development Operations and is part of the Development Operations Leadership team. Essential Duties and Responsibilities
Accountable for delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality. Develop and present the operational strategy and plans including supply chain to effectively execute the Clinical Development Plan. Partner 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, in compliance with ICH/GCP, local regulations and Kardigan’s SOPs. Drive selection, oversight, and management of CROs and other vendors. Oversee site feasibility/capability assessments in collaboration with the CRO and cross‑functional team. Own strategy and execution of innovative approaches (digital patient‑oriented data capture, novel clinical research platforms, collaborations). Provide clinical operations input into protocol, investigator brochure, regulatory documents, study reports and other documents. Lead and provide oversight to the trial‑specific operations team including CROs/vendors. Represent Clinical Operations on cross‑functional project teams, ensuring compliance with operational standards and procedures. Represent Kardigan 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 facilitate timely decision‑making by senior management. Collaborate on inspection readiness activities (audits, regulatory inspections). Maintain and participate in SOP review, training and maintenance. Lead or participate in Development Operations workstreams related to operating model initiatives. Develop and foster strong, collaborative relationships with key stakeholders both internally and externally. Directly manage assigned Clinical Trial Leads, focusing on performance, coaching and career development. 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; 6+ years of high‑complexity global trial management experience. Advanced degree preferred. Experience in cardiovascular or rare disease studies preferred. Robust experience in early and late‑phase drug development; some late‑stage development experience required. Multi‑dimensional Clinical Operations background with capability to devise plans for operational challenges. Cross‑collaboration proficiency with Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management. Proven track record of effective leadership and team‑building in a 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. Agility and innovative mindset. Compensation
Exact compensation may vary based on skills, experience and location. Pay range: $234,000 – $305,000 USD. Equal Employment Opportunity
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.
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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. Kardigan’s mission is 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. Core values:
Driven by patients and their families ;
Authentic ;
Eagerness to learn ;
Winning as a team ;
Enabling the impossible . 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‑Thu) Job Overview
Kardigan is seeking a Senior Director, Clinical Operations Program Lead for a late‑stage cardiovascular asset. This role will lead all activities associated with the clinical studies, including overseeing the internal operations team, CROs and vendors, and working cross‑functionally on the operational strategy and related initiatives. The position reports to the Head of Development Operations and is part of the Development Operations Leadership team. Essential Duties and Responsibilities
Accountable for delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality. Develop and present the operational strategy and plans including supply chain to effectively execute the Clinical Development Plan. Partner 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, in compliance with ICH/GCP, local regulations and Kardigan’s SOPs. Drive selection, oversight, and management of CROs and other vendors. Oversee site feasibility/capability assessments in collaboration with the CRO and cross‑functional team. Own strategy and execution of innovative approaches (digital patient‑oriented data capture, novel clinical research platforms, collaborations). Provide clinical operations input into protocol, investigator brochure, regulatory documents, study reports and other documents. Lead and provide oversight to the trial‑specific operations team including CROs/vendors. Represent Clinical Operations on cross‑functional project teams, ensuring compliance with operational standards and procedures. Represent Kardigan 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 facilitate timely decision‑making by senior management. Collaborate on inspection readiness activities (audits, regulatory inspections). Maintain and participate in SOP review, training and maintenance. Lead or participate in Development Operations workstreams related to operating model initiatives. Develop and foster strong, collaborative relationships with key stakeholders both internally and externally. Directly manage assigned Clinical Trial Leads, focusing on performance, coaching and career development. 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; 6+ years of high‑complexity global trial management experience. Advanced degree preferred. Experience in cardiovascular or rare disease studies preferred. Robust experience in early and late‑phase drug development; some late‑stage development experience required. Multi‑dimensional Clinical Operations background with capability to devise plans for operational challenges. Cross‑collaboration proficiency with Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management. Proven track record of effective leadership and team‑building in a 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. Agility and innovative mindset. Compensation
Exact compensation may vary based on skills, experience and location. Pay range: $234,000 – $305,000 USD. Equal Employment Opportunity
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.
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