Vice President, Clinical Development

Role Summary

The Vice President, Clinical Development will serve as the strategic clinical lead for one or more IND programs and/or ongoing clinical trials in solid tumors or hematologic malignancies. The ideal candidate will have a proven track record of success in clinical trial leadership across academic, biotechnology, and pharmaceutical settings, with emphasis on developing and executing clinical strategy, interpreting clinical data, and fostering relationships with industry KOLs, medical experts, and investigators. The role focuses on strategic oversight and leadership of clinical development programs, with medical monitoring responsibilities as needed. Location: On site in San Diego, CA.

Responsibilities

• Provide strategic oversight and direction for one or more clinical trial programs, ensuring alignment with organizational goals and regulatory requirements
• Lead the design, development, and implementation of clinical trial strategies and plans in partnership with Pre-clinical R&D, Clinical Operations, Regulatory Affairs, Quality Assurance, and Janux’s Management Committee
• Oversee the execution of clinical development programs, including protocol development, data interpretation, and decision-making at key program milestones
• Serve as a source of medical expertise and provide high-level guidance to cross-functional teams, clinical project staff, and investigative sites
• Perform the duties of a Medical Monitor as needed to ensure clinical integrity and patient safety, while delegating operational aspects where appropriate
• Provide subject matter expertise and medical review and/or input within the preparation of medical components of clinical trial and regulatory documents which may include, but is not limited to the following: Clinical Development Plans, Clinical Study Reports, Investigator Brochures, SAE Narratives, INDs, and/or Annual Reports
• Contribute to CRO, clinical site and investigator training; actively interact with CROs, clinical sites and investigators regarding study implementation
• Respond to clinical questions from sites, IRBs/IECs, Health Authorities and CROs
• Review, interpret and present clinical data to both internal and external key stakeholders
• Establish and maintain relationships with KOLs, medical experts and investigators in the area of Immuno-Oncology and genitourinary disease areas
• Other duties as deemed essential

Qualifications

• Required: MD or DO with subspecialty in Oncology, specifically genitourinary cancers
• Required: Post-graduate training or residency in Oncology
• Preferred: Board certification or board eligibility
• Required: Minimum 8 years of experience within biotechnology, pharmaceutical or relevant academic institutions
• Required: Expert-level understanding of early drug development and clinical trial processes with a track record of leading clinical development programs
• Required: Knowledge of GCP and ICH guidelines and regulatory requirements for oncology clinical trials, particularly in prostate cancer
• Required: Strong ability to critically evaluate data, literature, and presentations
• Required: High level of communication skills