Executive Director, Clinical Pharmacology

The role

The Executive Director, Clinical Pharmacology provides strategic and scientific leadership for the Clinical Pharmacology function across the cardiovascular development portfolio. This person will define clinical pharmacology strategies, lead regulatory interactions with health authorities, and build internal capabilities.

What you will do

• Provide executive-level strategic leadership and operational ownership of the Clinical Pharmacology function.
• Define, develop, and execute integrated clinical pharmacology strategies across multiple development programs.
• Serve as the senior clinical pharmacology leader and primary strategic representative for FDA and other global health authority interactions.
• Lead strategic oversight of clinical pharmacology components including dose selection, PK/PD modeling, and drug-drug interaction assessments.
• Provide scientific oversight for pharmacometric analyses.
• Oversee external clinical pharmacology consultants and vendors.
• Collaborate with cross-functional partners to integrate clinical pharmacology strategy into overall program plans.
• Author and review clinical pharmacology sections of regulatory documents including INDs and NDA submissions.
• Present clinical pharmacology strategies and recommendations to senior leadership and governance committees.
• Establish and strengthen the Clinical Pharmacology function, including scientific standards and resource planning.

Required qualifications

• Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Pharmacokinetics, or a related scientific discipline.
• Approximately 15+ years of clinical pharmacology experience within the biotechnology and/or pharmaceutical industry.
• Significant strategic and functional leadership responsibility across multiple clinical development programs.
• Experience defining, developing, and leading integrated clinical pharmacology strategies for early and late-stage clinical development.
• Experience with the design, conduct, and interpretation of clinical pharmacology studies such as drug-drug interaction, food effect, and special populations.
• Expertise in population pharmacokinetics (PopPK), PK/PD modeling, exposure-response analyses, dose optimization, and model-informed drug development.
• Experience serving as the clinical pharmacology lead for FDA and other global regulatory agency interactions.
• Experience leading clinical pharmacology contributions 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.
• Success leading cross-functional initiatives and influencing strategy within a matrix organization.
• Ability to establish functional strategy, manage external partnerships, and build organizational capabilities.
• Excellent leadership, communication, presentation, and scientific writing skills.

Nice to have

• Experience supporting cardiovascular or cardiometabolic drug development programs.
• Previous experience playing a leadership role in 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.
• Ability to balance strategic leadership with hands-on execution in a fast-paced, collaborative environment.
• Strong problem-solving, decision-making, and organizational skills.

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Its mission is to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.