Executive Director, Clinical Pharmacology

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, and critical decision-making. 

• Establish and continuously strengthen the Clinical Pharmacology function, including scientific standards, governance processes, resource planning, and the strategic use of internal and external expertise. 

• Provide functional leadership, mentorship, and scientific guidance to internal team members and external partners, supporting organizational capability development and future team growth as appropriate. 

• Stay current with evolving regulatory guidance, scientific advances, and industry best practices to continuously strengthen Kardigan’s clinical pharmacology capabilities and proactively identify opportunities to improve development efficiency, scientific innovation, and regulatory success. 

Qualifications and Experience

Minimum 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, including significant strategic and functional leadership responsibility across multiple clinical development programs. 

• Demonstrated experience defining, developing, and leading integrated clinical pharmacology strategies supporting early and late-stage clinical development, including portfolio-level strategic planning and decision-making. 

• 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, including the ability to lead complex scientific discussions and influence regulatory strategy. 

• 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. 

• Demonstrated success leading cross-functional initiatives and influencing scientific and development strategy within a matrix organization, including the ability to drive alignment and decision-making at the senior leadership level. 

• Demonstrated ability to establish functional strategy, manage external partnerships, and build organizational capabilities in a dynamic development environment. 

• Excellent leadership, communication, presentation, and scientific writing skills, with demonstrated executive presence and the ability to communicate complex scientific concepts and strategic recommendations to senior leadership and diverse stakeholders. 

Preferred Qualifications

• 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, including establishing functional infrastructure, operating models, and resource strategies. 

• 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 and navigate complex development challenges with sound scientific and business judgment. 

Equal Employment Opportunity

Kardigan is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, gender identity, gender expression, and sexual orientation), national origin, age, disability, genetic information, veteran status, marital status, citizenship status, or any other characteristic protected by applicable federal, state, or local law. We are committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application and employment process.