Janux Therapeutics
Vice President, Biometrics
San Diego, CA · Exec
Work authorization required$330k-$360kDetected 34 days ago
GCPData AnalysisStatisticsComplianceBusiness DevelopmentClinical TrialsFDA RegulatoryPharmacovigilanceSASExperimental DesignAnimal StudiesLeadershipCommunicationOrganizational SkillsBiostatisticsRegulatory Affairs
About the role
- This role is responsible for Biostatistics, Statistical Programming, and Clinical Data Management, and will serve as the functional head of Biometrics at Janux.
- This role requires a highly strategic and collaborative leader who can also operate hands-on in a dynamic, fast-paced clinical-stage biotech environment.
Responsibilities
- Build, lead, and develop a high-performing biometrics organization, including internal staff, consultants, and external partners (e.g., CROs and vendors).
- Lead biometrics strategy and execution across clinical development programs from early development through submission readiness and post-submission support.
- Serve as the biometrics functional lead on cross-functional development teams, contributing to study design, statistical strategy, endpoint selection, and key development decisions.
- Oversee the design, analysis, and interpretation of clinical trials and preclinical studies, ensuring scientific rigor, regulatory compliance, and high-quality data standards.
- Collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Sciences, Pharmacovigilance, and Quality teams to ensure alignment on study design, execution, and data quality.
- Provide oversight of CRO and vendor deliverables, including database build, CRF design, data review, programming outputs, and TLF production, ensuring quality, timelines, and cost-effectiveness.
- Establish and maintain biometrics systems, standards, processes, and SOPs, including frameworks for CRF development, data collection, database management, and data governance.
- Drive innovation in statistical methodology, adaptive trial design, data analytics, visualization, and technology-enabled processes to support program advancement and decision-making.
- The VP will work closely with senior leadership to shape clinical strategy, study design, regulatory planning, and data-driven decision-making.
- Support business development, diligence, and strategic partnership activities as the biometrics subject matter expert.
Requirements
- Up to 25% travel may be required, including domestic and occasional international travel for regulatory meetings, CRO oversight, investigator meetings, scientific conferences, and corporate activities.
- United States (Required)
Skills
- PhD in Biostatistics, Statistics, or a related quantitative discipline required.
- 15+ years of experience in biotechnology or pharmaceutical drug development, including significant leadership experience in biometrics.
- Proven experience leading integrated biometrics functions across Biostatistics, Statistical Programming, and Clinical Data Management.
- Strong executive presence with excellent communication, presentation, and influencing skills
- Demonstrated ability to operate effectively in a fast-paced, hands-on, clinical-stage biotech environment with evolving priorities.
- Commitment to scientific excellence, operational rigor, and continuous process improvement.
- Ability to travel up to 25% as business needs require.
Compensation
- Annual targeted bonus %
- Up to 25% travel may be required, including domestic and occasional international travel for regulatory meetings, CRO oversight, investigator meetings, scientific conferences, and corporate activities.
Benefits
- Annual bonus program
- Incentive stock option plan
- Comprehensive medical insurance with 90-100% employer-paid premiums
- Dental and vision insurance
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Generous holiday schedule
- Support and lead preparation for regulatory interactions and inspections; represent Biometrics in meetings with FDA, EMA, and other global health authorities as appropriate.
- Reporting to the Chief Medical Officer, the Vice President, Biometrics will lead and oversee all biometrics activities supporting clinical development from IND-enabling studies through regulatory submission.
Equal opportunity
- Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Visa & Work Authorization
- Work authorization:
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