Senior/Executive Director, Clin Pharmacology

AVENZO THERAPEUTICS INC • San Diego, CA

45d • $290,000 - $328,200 • Hybrid

About The Position

Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand. Our team is passionate about and committed to advancing a pipeline of potential best-in-class 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 Vice President, Clinical Pharmacology, the Senior Director/Executive Director, Clinical Pharmacology will help lead the design, analysis, and interpretation of clinical pharmacology strategies across our development programs. This role is ideal for a scientific leader who thrives on rolling up their sleeves, working closely with data, and directly influencing clinical and regulatory outcomes.

Requirements

• PhD required, advanced medical or life sciences or a related area degree preferred (e.g., MD, Pharm.D.) with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Direct experience designing and executing early-phase clinical studies, including healthy volunteer studies
• Strong expertise in PK analysis and exposure-response interpretation; experience in oncology preferred
• Experience managing external Clinical Pharmacology resources
• Proven track record of contributing to regulatory submissions and engaging with health authorities
• Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects
• Demonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds
• Expertise/experience in multiple clinical pharmacology areas is preferred
• Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings
• Experience in working in a cross functional team/matrix environment with strong vendor management skills
• Competent in the use of PK and PK/PD Modeling software tools
• 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

• Design and oversee pharmacokinetic (PK), pharmacodynamic (PD) and exposure-response analyses to support dose selection, study design, and benefit-risk assessments
• Propose and lead the development and execution of clinical pharmacology components of studies
• Provide scientific leadership for the clinical pharmacology components of clinical studies (including early-phase studies) from protocol concept through analysis, interpretation, and decision making
• Author, review, and approve clinical pharmacology content for regulatory submissions (e.g., INDs, CTAs, NDAs/MAAs, briefing packages) and support health authority interactions
• Collaborate with internal/external modeling experts to design and oversee population PK, exposure–response, and related analyses; ensure quality, interpretability, and timely delivery of outputs
• Serve as the clinical pharmacology lead on cross-functional program teams; translate pharmacologic insights into clear recommendations and influence program governance and development strategy
• Define analysis plans and interpretation frameworks for PK/PD data (including model-informed drug development approaches) and ensure alignment with global regulatory expectations for small-molecule therapeutics
• Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis
• Contribute to program-level planning and prioritization based on pharmacological insights and development risk
• Accountable and responsible for the analysis and interpretation of PK and PK/PD data

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Basic life and AD&D insurance
• Short-term disability insurance
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree