Job Title: Director, Pharmacometrics
Location: San Diego or Remote U.S.
Job Type: Full-Time
Position SummaryReporting to the VP, Clinical Pharmacology, the Director, Pharmacometrics will lead the development and execution of pharmacometrics strategies supporting Avenzo's oncology programs. This role is responsible for applying model-informed drug development approaches, including population PK, PK/PD, and exposure-response modeling, to guide dose optimization, study design, and regulatory decision-making. The Director will collaborate across functions and with external partners to generate quantitative insights that enable efficient clinical development and support regulatory submissions and interactions.
Essential Job Functions and Responsibilities- Provide strategic leadership and subject matter expertise in pharmacometrics and clinical pharmacology across our development portfolio
- Develop and execute model-informed drug development strategies, including population PK, PK/PD, exposure-response, and simulation analyses to support program decision-making
- Lead pharmacometric activities and contribute clinical pharmacology expertise as a core member of cross-functional program teams, partnering closely with Clinical Development, Biometrics, Regulatory Affairs, and other internal and external subject matter experts
- Develop and apply pharmacometric analyses to support dosing recommendations for special populations, dose modifications, drug-drug interactions, organ impairment, and other intrinsic and extrinsic factors
- Resolve complex scientific and technical challenges with cross-program impact, contributing to dose justification, benefit-risk assessments, and regulatory development strategies
- Analyze and interpret clinical and translational PK/PD data and oversee pharmacometric modeling activities to inform development and regulatory decisions
- Develop clinical pharmacology plans and dosing strategies from first-in-human studies through late-stage clinical development
- Author and review clinical pharmacology content for protocols, clinical study reports, regulatory submissions, briefing documents, and health authority interactions
- Represent Clinical Pharmacology and Pharmacometrics in regulatory agency meetings and responses, supporting global development and registration strategies
- Provide oversight of pharmacometric platforms, modeling environments, reporting workflows, and external vendors to ensure high-quality and efficient execution
- Manage pharmacometrics activities, budgets, timelines, and deliverables to ensure successful program execution
- Influence development strategy through quantitative analyses and scientific recommendations that support portfolio-wide objectives
Preferred Qualifications- PhD degree in pharmacometrics, biological/pharmaceutical sciences, bioengineering, biostatistics, engineering, data science, or a related disciplines with 8+ years of progressive pharmacometrics experience in the life sciences industry or an equivalent combination of academic and industry experience
- Demonstrated expertise in population PK/PD, exposure-response, and model-informed drug development approaches
- Extensive hands-on experience with pharmacometric software platforms, including NONMEM, Monolix, R, and other industry-standard modeling and simulation tools
- Deep understanding of clinical pharmacology and pharmacometric requirements for regulatory submissions, including IND, NDA, MAA, and NDS filings
- Proven experience leading and authoring modeling and simulation plans and directing pharmacometric analyses across Phase I-IV clinical development programs
- Strong knowledge of oncology drug development, clinical pharmacology principles, and regulatory guidelines
- Demonstrated ability to manage multiple priorities, projects, and deliverables through influence, matrix leadership, and effective stakeholder engagement
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
- Strong analytical and problem-solving abilities, with a strategic mindset
- This position requires periodic/regular travel, including up to 15% of work time, which may include overnight travel
Physical Demands and Work EnvironmentPhysical Demands:
- Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
- Constant or frequent sitting, standing, or walking
- May lift and/or move objects of various weights
Work Environment:
- Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
- San Diego-based: On-site requirement (Monday through Thursday)
- Noise level in the work environment is usually moderate
- Fast-paced, time-sensitive environment with frequently changing priorities
- Handle multiple projects simultaneously
Salary RangeThe salary range for this position is $234,000 to $250,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.
BenefitsProvided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.
Other CompensationThe hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.
The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.
Applications for this position are anticipated to close on November 30, 2026. For more information about this posting, please contact careers@avenzotx.com.
