Director, Clinical Pharmacology Lead
Scorpion Therapeutics, California, Missouri, United States, 65018
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.
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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.
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