Director, Pharmacometrics
AVENZO THERAPEUTICS INC
Summary
Reporting 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.
Job description
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
Requirements
- PhD degree in pharmacometrics, biological/pharmaceutical sciences, bioengineering, biostatistics, engineering, data science, or a related discipline
- 8+ years of progressive pharmacometrics experience in the life sciences industry or 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
Benefits
- Medical, Dental & Vision
- Basic Life & AD&D
- Short-term & Long-term Disability
- Flexible Spending Accounts
- Health Savings Accounts
- Voluntary Life & AD&D
- Critical Illness Insurance
- 401(k) Plan
- Paid Vacation Time
- Paid Sick Leave
- 17 Paid Holidays
- Annual Discretionary Bonus
- Equity Award
Company overview
Avenzo Therapeutics is a clinical-stage biotechnology company founded in 2022 and headquartered in San Diego, California, dedicated to developing the next generation of oncology therapies to transform cancer treatment. The company focuses on creating potentially best-in-class or first-in-class targeted therapies for solid tumors and cancers with high unmet medical needs. Avenzo's pipeline includes innovative antibody-drug conjugates (ADCs) and selective kinase inhibitors targeting validated oncology pathways, with multiple programs currently in Phase 1/2 clinical development. The company was founded by experienced oncology drug development veterans, including CEO Athena Countouriotis, M.D., who previously led Turning Point Therapeutics through its successful acquisition by Bristol Myers Squibb. Avenzo has raised significant venture capital funding, including a $60 million Series B round in 2025, and is backed by prominent investors including OrbiMed, SR One, and Lilly Asia Ventures. The company's approach combines deep oncology expertise with strategic in-licensing of promising assets to build a diversified portfolio of targeted cancer therapies.