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Janux Therapeutics · 1 week ago

Director, Clinical Pharmacology Lead

San Diego County, CA

Full-time

Onsite

Director/Executive

$232K/yr - $254K/yr

6+ years exp

Janux Therapeutics is seeking a hands-on, execution-driven Clinical Pharmacology Lead to support the design, analysis, and interpretation of clinical pharmacology strategies across their development programs. This role focuses on executional excellence and involves overseeing clinical pharmacology plans, analyses, and regulatory documentation.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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

Qualification

Clinical PharmacologyPK AnalysisRegulatory SubmissionsPharmaceutical SciencesPharmacometricsCommunication SkillsCollaboration SkillsOrganizational SkillsIndependent Work