Role Summary
Janux Therapeutics is seeking a hands-on, execution-driven Clinical Pharmacology Lead to support the design, analysis, and interpretation of clinical pharmacology strategies across our development programs. This role is ideal for a scientific contributor who thrives on working directly with data, ensuring high-quality PK analysis, and enabling data-informed decisions for dose selection and regulatory filings. Location: On-site in San Diego, CA.
Responsibilities
- Serve as the Clinical Pharmacology Lead across multiple programs, owning the execution of clinical pharmacology plans from IND through early clinical 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 components of 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 support regulatory interactions.
- Ensure proper bioanalytical sampling strategies, assay validation, and data quality across studies.
- Collaborate with Translational Medicine and Biomarker teams to integrate mechanistic and biomarker data into PK/PD interpretation.
- Work closely with Biometrics and external modeling partners to support population PK and exposure–response modeling.
- Stay current with regulatory guidance and scientific advances in clinical pharmacology, applying best practices to development programs.
- Contribute to program-level planning and prioritization based on pharmacological insights and development risk.
- Other activities as required.
Qualifications
- Required: Ph.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
- Required: 6+ years of experience in clinical pharmacology and/or pharmacometrics in the biotech or pharmaceutical industry.
- Required: Direct experience designing and executing early-phase clinical studies, including healthy volunteer studies.
- Required: Strong expertise in PK analysis and exposure–response interpretation; experience in oncology or biologics preferred.
- Required: Familiarity with T cell engagers (TCE) and managing external Clinical Pharmacology resources.
- Required: Proven track record of contributing to regulatory submissions and engaging with health authorities.
- Required: Excellent communication, collaboration, and organizational skills.
- Required: Ability to work independently and in a fast-paced, matrixed environment.
- Required: Ability to travel up to 15%.
Skills
- Strong analytical and data interpretation abilities
- Collaborative cross-functional teamwork
- Effective scientific communication and regulatory writing
Education
- Ph.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
Additional Requirements
- Travel up to 15%.
- On-site work location: San Diego, CA.