Executive Director, Clinical Pharmacology
kardigan
3 months ago
Full-time
On-site
Princeton, New Jersey, United States
$255,000 - $332,000 USD yearly
Executive
Moneyboard classification: Published range reaches threshold
Reported USD annual base: $255,000–$332,000
Original source: Greenhouse
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.
About the Job
Job Title: Executive Director, Clinical Pharmacology
Level: Executive Director
Department: Early Development
Hiring Manager: Vice President, Early Development
Location: Princeton, NJ
Classification: Hybrid – On-site 4 days per week (Mon to Thurs)
Job Overview
Reporting to the Vice President, Early Development, the Executive Director, Clinical Pharmacology will provide enterprise-level strategic and scientific leadership for the Clinical Pharmacology function across Kardigan’s cardiovascular development portfolio. This individual will be responsible for defining, establishing, and driving clinical pharmacology strategies from early through late-stage development, supporting regulatory submissions, and serving as the company’s senior clinical pharmacology leader and strategic representative for FDA and other global health authority interactions. This role will partner cross-functionally with senior leaders to shape portfolio priorities, inform critical development decisions, and ensure successful development and registration strategies.
This is a highly visible executive-level leadership position requiring both strategic vision and hands-on execution within a fast-paced, collaborative biotechnology environment. The Executive Director will play a critical role in building and advancing Kardigan’s internal clinical pharmacology capabilities, establishing scientific standards, and ensuring the function effectively supports the company’s long-term pipeline and organizational objectives.
Essential Duties and Responsibilities
Provide executive-level strategic leadership, functional direction, and operational ownership of the Clinical Pharmacology function, transitioning activities currently supported by external consultants into a sustainable, internally led capability aligned with Kardigan’s portfolio and growth objectives.
Define, develop, and execute integrated clinical pharmacology strategies across multiple development programs from early phase through late-stage clinical development and regulatory submission, ensuring alignment with portfolio priorities, development milestones, and regulatory objectives.
Serve as the senior clinical pharmacology leader and primary strategic representative for FDA and other global health authority interactions, including INDs, End-of-Phase meetings, briefing documents, and future NDA submissions, providing scientific leadership and strategic guidance on complex regulatory matters.
Lead and provide strategic oversight of clinical pharmacology components of development plans, including dose selection, dose optimization, exposure-response analyses, population pharmacokinetic (PopPK) analyses, PK/PD modeling, food effect studies, drug-drug interaction assessments, QT evaluations, and special population strategies.
Provide scientific oversight for pharmacometric analyses and collaborate with internal and external experts to ensure high-quality interpretation of clinical pharmacology data and its integration into critical program and portfolio-level decisions.
Oversee external clinical pharmacology consultants and vendors, ensuring scientific excellence, timely execution, and high-quality deliverables, while developing an effective operating model, resource strategy, and internal capabilities to support evolving business needs.
Collaborate closely with Clinical Development, Clinical Operations, Translational Medicine, Biometrics, Regulatory Affairs, Medical Writing, CMC, Research, and other cross-functional partners to integrate clinical pharmacology strategy into overall program and development plans, influencing key decisions and driving alignment across functions and leadership teams.
Provide strategic direction for, author and review clinical pharmacology sections of regulatory documents, including INDs, Investigator’s Brochures, briefing books, clinical study reports, NDA submissions, and responses to health authority questions, ensuring scientific rigor, consistency, and regulatory readiness.
Present clinical pharmacology strategies, data, and recommendations to senior leadership, governance committees, and external stakeholders, serving as a trusted scientific advisor on development strategy, risk assessment,
Reported USD annual base: $255,000–$332,000
Original source: Greenhouse
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.
About the Job
Job Title: Executive Director, Clinical Pharmacology
Level: Executive Director
Department: Early Development
Hiring Manager: Vice President, Early Development
Location: Princeton, NJ
Classification: Hybrid – On-site 4 days per week (Mon to Thurs)
Job Overview
Reporting to the Vice President, Early Development, the Executive Director, Clinical Pharmacology will provide enterprise-level strategic and scientific leadership for the Clinical Pharmacology function across Kardigan’s cardiovascular development portfolio. This individual will be responsible for defining, establishing, and driving clinical pharmacology strategies from early through late-stage development, supporting regulatory submissions, and serving as the company’s senior clinical pharmacology leader and strategic representative for FDA and other global health authority interactions. This role will partner cross-functionally with senior leaders to shape portfolio priorities, inform critical development decisions, and ensure successful development and registration strategies.
This is a highly visible executive-level leadership position requiring both strategic vision and hands-on execution within a fast-paced, collaborative biotechnology environment. The Executive Director will play a critical role in building and advancing Kardigan’s internal clinical pharmacology capabilities, establishing scientific standards, and ensuring the function effectively supports the company’s long-term pipeline and organizational objectives.
Essential Duties and Responsibilities
Provide executive-level strategic leadership, functional direction, and operational ownership of the Clinical Pharmacology function, transitioning activities currently supported by external consultants into a sustainable, internally led capability aligned with Kardigan’s portfolio and growth objectives.
Define, develop, and execute integrated clinical pharmacology strategies across multiple development programs from early phase through late-stage clinical development and regulatory submission, ensuring alignment with portfolio priorities, development milestones, and regulatory objectives.
Serve as the senior clinical pharmacology leader and primary strategic representative for FDA and other global health authority interactions, including INDs, End-of-Phase meetings, briefing documents, and future NDA submissions, providing scientific leadership and strategic guidance on complex regulatory matters.
Lead and provide strategic oversight of clinical pharmacology components of development plans, including dose selection, dose optimization, exposure-response analyses, population pharmacokinetic (PopPK) analyses, PK/PD modeling, food effect studies, drug-drug interaction assessments, QT evaluations, and special population strategies.
Provide scientific oversight for pharmacometric analyses and collaborate with internal and external experts to ensure high-quality interpretation of clinical pharmacology data and its integration into critical program and portfolio-level decisions.
Oversee external clinical pharmacology consultants and vendors, ensuring scientific excellence, timely execution, and high-quality deliverables, while developing an effective operating model, resource strategy, and internal capabilities to support evolving business needs.
Collaborate closely with Clinical Development, Clinical Operations, Translational Medicine, Biometrics, Regulatory Affairs, Medical Writing, CMC, Research, and other cross-functional partners to integrate clinical pharmacology strategy into overall program and development plans, influencing key decisions and driving alignment across functions and leadership teams.
Provide strategic direction for, author and review clinical pharmacology sections of regulatory documents, including INDs, Investigator’s Brochures, briefing books, clinical study reports, NDA submissions, and responses to health authority questions, ensuring scientific rigor, consistency, and regulatory readiness.
Present clinical pharmacology strategies, data, and recommendations to senior leadership, governance committees, and external stakeholders, serving as a trusted scientific advisor on development strategy, risk assessment,