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.