Director, Quantitative Pharmacology, Clinical Pharmacology

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Quantitative Pharmacology, Clinical Pharmacology in the United States.

This senior leadership role sits at the core of clinical drug development, driving quantitative and model-informed strategies across the full lifecycle of innovative therapies. The position leads clinical pharmacology and PK/PD activities from early development through late-stage programs and regulatory submissions, ensuring scientifically rigorous, data-driven decision-making. Working at the intersection of clinical science, pharmacometrics, and regulatory strategy, the role has a direct impact on dose optimization, study design, and patient outcomes. It requires close collaboration with cross-functional teams including non-clinical, bioanalytical, formulation, and regulatory experts. Operating in a highly matrixed and fast-evolving environment, the role combines scientific depth with strategic leadership. It also plays a key part in advancing model-based drug development and innovative analytical approaches across the organization.

• Lead and oversee clinical pharmacology strategy across all development phases (pre-IND, IND, Phase I–III), including study design, execution, PK/PD analysis, and interpretation of clinical data.
• Drive quantitative pharmacology and model-informed drug development, partnering with pharmacometrics teams on simulation, modeling, and exposure-response analyses.
• Author and review key regulatory documentation including INDs, NDAs, IBs, annual reports, and pediatric development plans.
• Collaborate with bioanalytical, formulation, and non-clinical teams to support assay development, biomarker strategy, drug interactions, and formulation evaluation.
• Lead clinical pharmacology contributions to cross-functional development teams, including dose selection, optimization strategies, and early asset evaluation.
• Oversee external vendors, project budgets, SOWs, and financial tracking for clinical pharmacology and PK/PD activities.
• Mentor and develop scientific staff while contributing to organizational capability in quantitative pharmacology and advanced modeling approaches.

Requirements

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutics, or a related discipline with 10+ years of relevant industry experience.
• Strong expertise in PK/PD, drug metabolism, biopharmaceutics, and clinical pharmacology principles across early and late-stage development.
• Hands-on experience with PK/PD analysis tools (e.g., Phoenix NLME) and familiarity with pharmacometrics and model-based drug development approaches.
• Proven track record in leading clinical pharmacology strategy and regulatory submissions within a highly regulated pharmaceutical environment.
• Deep understanding of Phase I clinical operations, global regulatory requirements, and translational drug development.
• Strong leadership capabilities with experience mentoring teams and influencing cross-functional stakeholders in matrix organizations.
• Excellent communication, scientific writing, and presentation skills with the ability to translate complex data into actionable insights.
• Ability to adapt quickly in a dynamic environment and manage multiple priorities effectively.

Benefits

• Competitive base salary with performance-based incentive opportunity
• Comprehensive medical, dental, and vision insurance coverage
• Short-term and long-term disability, life insurance, and prescription drug coverage
• 401(k) retirement plan with company match
• Tuition reimbursement and student loan assistance programs
• Flexible time off, paid holidays, and paid leave programs
• Hybrid or remote flexibility depending on location requirements
• Employee wellbeing and support programs, including mental health resources
• Professional development and internal growth opportunities.