Job OverviewReporting to the Vice President, Early Development, the Senior Director, Clinical Pharmacology will provide strategic and scientific leadership for the Clinical Pharmacology function across Kardigan's cardiovascular development portfolio. This individual will be responsible for establishing and executing clinical pharmacology strategies from early through late-stage development, supporting regulatory submissions, and serving as the company's clinical pharmacology lead for FDA and other global health authority interactions. This role will partner cross-functionally to ensure successful development and registration strategies.
This is a highly visible leadership position requiring both strategic vision and hands-on execution within a fast-paced, collaborative biotechnology environment.
Essential Duties and 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.
Qualifications and Experience Minimum Qualifications- 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.
Preferred Qualifications- 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.
