Senior/Executive Director, Clin Pharmacology

Avenzo Therapeutics

$290K — $328K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Ph.D. or equivalent in life sciences with 12+ years in the industry.
  • Direct experience in designing early-phase clinical studies.
  • Strong expertise in PK analysis and exposure-response interpretation, preferably in oncology.
  • Experience managing external Clinical Pharmacology resources and regulatory submissions.
  • Demonstrated ability to develop clinical pharmacology strategy and design studies for PK and PK/PD relationships.

Responsibilities

  • Design and oversee pharmacokinetic (PK) and pharmacodynamic (PD) analyses for clinical studies.
  • Lead the development and execution of clinical pharmacology components in studies.
  • Provide scientific leadership from protocol concept through analysis and decision making.
  • Author and approve clinical pharmacology content for regulatory submissions.
  • Collaborate with modeling experts for population PK and related analyses.
  • Serve as clinical pharmacology lead on cross-functional program teams.
  • Define analysis plans for PK/PD data and ensure alignment with regulatory expectations.

Benefits

  • Comprehensive healthcare plans including medical, dental, and vision.
  • Short-term and long-term disability insurance options.
  • Flexible spending accounts and health savings accounts available.
  • Generous paid vacation and sick leave accrual.
  • 17 paid holidays each year including a winter closure.
  • Eligibility for annual bonus and equity award.
Full Job Description
Job Title: Senior Director/Executive Director, Clinical Pharmacology

Location: San Diego, California or Remote U.S.

Job Type: Full-Time

Position 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.

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


Physical Demands and Work Environment

Physical Demands:

  • Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
  • Constant or frequent sitting, standing, or walking
  • May lift and/or move objects of various weights


Work Environment:

  • San Diego-based: On-site requirement (Monday through Thursday)
  • Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
  • Noise level in the work environment is usually moderate
  • Fast-paced, time sensitive environment with frequently changing priorities
  • Handle multiple projects simultaneously


Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Salary Range

The salary range for this position for a Senior Director is $290,000 to $301,000 per year and for an Executive Director $318,000 to $328,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Benefits

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.

Other Compensation

The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.

Applications for this position are anticipated to close on June 30, 2026. For more information about this posting, please contact [email protected].

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