Director, Clinical Pharmacology in United States Embassy at Jobgether
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Job Description
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.
- 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.
- 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.
- 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.