Senior Director, Clinical Pharmacology

Kardigan•Princeton, NJ

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments for cardiovascular diseases. Led by experienced co-founders who previously led MyoKardia, Kardigan possesses a strong discovery and translational research platform, a pipeline of late-stage candidates, and a driven team focused on patient well-being. The company's values emphasize patient-centricity, authenticity, continuous learning, teamwork, and enabling innovation through calculated risk-taking.

Requirements

Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Pharmacokinetics, or a related scientific discipline.
Approximately 12+ years of clinical pharmacology experience within the biotechnology and/or pharmaceutical industry, including leadership responsibility for clinical development programs.
Demonstrated experience developing and leading clinical pharmacology strategies supporting early and late-stage clinical development.
Demonstrated experience with the design, conduct, and interpretation of clinical pharmacology studies such as drug-drug interaction, food effect, and special populations
Expertise in the application of population pharmacokinetics (PopPK), pharmacokinetic/pharmacodynamic (PK/PD) modeling, exposure-response analyses, dose optimization, and model-informed drug development to enable clinical development decisions.
Proven experience serving as the clinical pharmacology lead for FDA and other global regulatory agency interactions.
Experience contributing to INDs, regulatory briefing packages, NDA/BLA submissions, and responses to regulatory questions.
Strong understanding of global regulatory expectations related to clinical pharmacology and quantitative drug development.
Demonstrated success leading cross-functional initiatives and influencing scientific and development strategy within a matrix organization.
Excellent leadership, communication, presentation, and scientific writing skills.

Nice To Haves

Experience supporting cardiovascular or cardiometabolic drug development programs.
Previous experience supporting one or more successful NDA and/or BLA submissions.
Experience building or expanding clinical pharmacology capabilities within an emerging biotechnology company.
Familiarity with quantitative systems pharmacology approaches.
Demonstrated ability to balance strategic leadership with hands-on execution in a fast-paced, collaborative environment.
Strong problem-solving, decision-making, and organizational skills with the ability to manage multiple priorities simultaneously.

Responsibilities

Provide strategic leadership and operational ownership of the Clinical Pharmacology function, transitioning activities currently supported by external consultants into an internally led capability.
Develop and execute clinical pharmacology strategies across multiple development programs from early phase through late-stage clinical development and regulatory submission.
Serve as the primary clinical pharmacology representative for FDA and other global health authority interactions, including INDs, End-of-Phase meetings, briefing documents, and future NDA submissions.
Lead 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.
Oversee external clinical pharmacology consultants and vendors, ensuring scientific excellence, timely execution, and high-quality deliverables.
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.
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.
Present clinical pharmacology strategies, data, and recommendations to senior leadership, governance committees, and external stakeholders.
Stay current with evolving regulatory guidance, scientific advances, and industry best practices to continuously strengthen Kardigan's clinical pharmacology capabilities.