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Executive Director, Clinical Pharmacology
Janux Therapeutics, Inc.San Diego, United Statesfull_timeVerifiedPosted 28 May 2025
About the role
Janux Therapeutics is seeking a hands-on, execution-driven Executive Director of Clinical Pharmacology to 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.
As a key member of the clinical development leadership team, you will be responsible for both strategic direction and day-to-day execution of clinical pharmacology deliverables. You’ll work cross-functionally to ensure that pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response data are fully leveraged to guide dose selection, study design, and regulatory strategy.
As a key member of the clinical development leadership team, you will be responsible for both strategic direction and day-to-day execution of clinical pharmacology deliverables. You’ll work cross-functionally to ensure that pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response data are fully leveraged to guide dose selection, study design, and regulatory strategy.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Serve as the Clinical Pharmacology Lead for multiple programs, owning the strategy and execution of clinical pharmacology plans from IND through late-stage development.
- Design and oversee PK, PK/PD, and exposure-response analyses to support dose selection, study design, and benefit-risk assessments.
- Lead the development and execution of clinical pharmacology studies, including food effect, drug-drug interaction, organ impairment, and QT assessments.
- Author and review clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs, briefing books) and represent Janux in regulatory meetings.
- Ensure proper bioanalytical sampling strategies, assay validation, and data quality across studies.
- Partner with Translational, Pharmacology and/or Biomarker teams to integrate biomarker and mechanistic data into PK/PD models and clinical decision-making.
- Work closely with Biometrics to develop and validate population PK and exposure-response models.
- Provide scientific leadership and mentorship to internal team members, fostering a culture of collaboration, innovation, and accountability.
- Contribute to portfolio-level planning, helping prioritize programs and allocate resources based on pharmacological insights and development risk.
- Stay current with regulatory guidance and scientific advances in clinical pharmacology, applying best practices to Janux’s development programs
- Other activities as required.
REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES
- Ph.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
- 10+ years of experience in clinical pharmacology and/or pharmacometrics in the biotech or pharmaceutical industry.
- Direct experience designing and executing early-phase clinical studies, including those involving healthy volunteers. Experience in oncology will be highly preferred.
- Demonstrated success in leading clinical pharmacology strategy and execution across multiple programs, in all phases of development.
- Deep expertise in model-informed drug development (MIDD), including population PK, PK/PD modeling, and exposure-response analysis.
- Strong track record of contributing to regulatory submissions and engaging with global health authorities.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Strong organizational and time management abilities.
- High level of accountability, adaptability, and attention to detail.
- Ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Ability to travel up to 15%
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