Senior/Executive Director, Clin Pharmacology
About the role
Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. The Senior Director/Executive Director, Clinical Pharmacology will lead the design, analysis, and interpretation of clinical pharmacology strategies across the Company's development programs.
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
Contribute to program-level planning and prioritization based on pharmacological insights and development risk
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
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
Preferred Qualifications
Experience in oncology
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
Benefits
Group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
Short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs
401(k) plan
Accrued paid vacation and sick leave
17 paid holidays each calendar year, including a winter closure
Annual discretionary bonus and equity award
Pay
$290,000 to $301,000 per year for a Senior Director and $318,000 to $328,000 per year for an Executive Director
Schedule
On-site requirement (Monday through Thursday) with occasional travel to San Diego headquarters
Benefits
Group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
Short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs
401(k) plan
Accrued paid vacation and sick leave
17 paid holidays each calendar year, including a winter closure
Annual discretionary bonus and equity award