Director, Pharmacometrics

AVENZO THERAPEUTICS INC•San Diego, CA

7d•$234,000 - $250,000•Hybrid

About The Position

Avenzo Therapeutics, Inc. (“Avenzo” or “Company”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California. 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.

Requirements

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

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

Benefits

medical insurance
dental insurance
vision insurance
basic life and AD&D insurance
short-term and long-term disability insurance
flexible spending accounts
health savings accounts
voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
401(k) plan
10 hours of paid vacation time every month
1 hour of paid sick leave for every 30 hours worked
17 paid holidays each calendar year, including a winter closure