Director, Clinical Pharmacology

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Clinical Pharmacology based in United States.

Join a highly collaborative clinical development organization where you'll play a pivotal role in advancing innovative therapies for patients with serious and underserved medical conditions. In this leadership position, you'll define and execute clinical pharmacology and pharmacometric strategies across a diverse pipeline, partnering with multidisciplinary teams from early discovery through late-stage development. You'll help shape regulatory strategies, optimize clinical study designs, and leverage advanced modeling approaches to accelerate decision-making. This role offers the opportunity to influence critical development milestones while working in a dynamic, science-driven environment that values innovation, collaboration, and meaningful patient impact. Remote work is available for U.S.-based candidates, with occasional travel for team collaboration and company events.

Accountabilities:: Lead the clinical pharmacology and pharmacometric strategy across multiple clinical development programs, ensuring alignment with overall product development objectives.

Provide scientific leadership for Phase 1 through Phase 3 clinical studies, including the design of dedicated clinical pharmacology trials and dose optimization strategies.

Oversee pharmacokinetic (PK), pharmacodynamic (PK/PD), exposure-response, and exposure-safety analyses using modeling and simulation approaches to support critical development decisions.

Author and review clinical pharmacology content for regulatory submissions, including Investigator's Brochures, INDs, NDAs, and responses to health authority inquiries.

Represent clinical pharmacology during regulatory interactions and contribute to the development of innovative strategies that accelerate patient access to new therapies.

Collaborate closely with cross-functional teams across clinical development, translational sciences, regulatory affairs, biostatistics, toxicology, and discovery research.

Guide external partners and internal stakeholders to ensure timely, high-quality delivery of pharmacology-related activities throughout the drug development lifecycle.

Apply advanced quantitative modeling techniques to solve complex drug development challenges and support evidence-based decision-making.

Requirements

Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related discipline; MD with Clinical Pharmacology expertise; or PharmD with a Clinical Pharmacology fellowship.

Approximately 5–9+ years of clinical pharmacology experience within the biotechnology or pharmaceutical industry.

Proven experience leading clinical pharmacology strategy across multiple stages of drug development.

Strong expertise in PK, PK/PD, population PK modeling, exposure-response analyses, and model-informed drug development.

Proficiency with industry-standard software such as WinNonlin, NONMEM, Monolix, R, or equivalent pharmacometric tools.

Demonstrated experience preparing regulatory submissions and participating in interactions with global health authorities.

Excellent collaboration, communication, and stakeholder management skills, with the ability to influence cross-functional teams.

Strong analytical mindset, scientific rigor, and problem-solving capabilities in complex development environments.

Experience in oncology is preferred, while expertise in rare diseases or other therapeutic areas is also highly valued.

Self-motivated, adaptable, and comfortable working within a fast-paced, innovative organization.

Benefits

Remote-first opportunity for candidates based in the United States, with occasional on-site collaboration and departmental events.

Competitive annual compensation aligned with experience and qualifications.

Annual performance bonus and equity participation.

Comprehensive health, wellness, and insurance benefits.

Generous paid time off and additional company-supported leave programs.

Opportunities to contribute to cutting-edge clinical development programs using advanced AI-enabled technologies.

Collaborative, mission-driven culture focused on innovation, continuous learning, and professional growth.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1