Senior/Executive Director, Clin Pharmacology
AVENZO THERAPEUTICS INC
Summary
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.
Job description
Essential Job Functions and 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
Preferred Qualifications
- 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
This position requires periodic/regular travel, including up to 15% of work time, which may include overnight travel.
Requirements
- PhD required
- Advanced medical or life sciences or a related area degree preferred (e.g., MD, Pharm.D.)
- 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 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
- 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
Benefits
- Medical, Dental & Vision
- Basic Life & AD&D
- Short-term Disability
- Long-term Disability
- Flexible Spending Accounts
- Health Savings Accounts
- Voluntary Life Insurance
- Voluntary AD&D
- Critical Illness Insurance
- 401(k) Plan
- Paid Vacation
- Paid Sick Leave
- 17 Paid Holidays
- Discretionary Annual 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.