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.
Accountabilities:- 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.
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.
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