Vice President, Clinical Development

Role Summary

The Vice President, Clinical Development will serve as the strategic clinical lead for one or more of Janux’s IND programs and/or ongoing clinical trials in solid tumors or hematologic malignancies. The ideal candidate will demonstrate a proven track record of success in clinical trial leadership within academic, biotechnology, and/or pharmaceutical industries, with a strong emphasis on developing and executing clinical strategy, interpreting clinical data, and fostering productive relationships with industry KOLs, medical experts, and investigators. While experience in medical monitoring is important, the primary focus of this role is on strategic oversight and leadership of clinical development programs.

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‚Äôs 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, etc.
• 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 more importantly, within the genitourinary disease areas
• Other duties as deemed essential

Qualifications

• MD or DO with a subspeciality in Oncology, more specifically in the treatment of genitourinary cancers is required
• Successful completion of post-graduate training or residency in Oncology, along with board certification or board eligibility is highly desirable
• 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 is essential
• Knowledge of GCP and ICH guidelines and regulatory requirements for the conduct of Oncology clinical trials, particularly in the treatment of prostate cancer
• Strong ability to critically evaluate data, literature, and presentations
• High level of communication skills is expected

Skills

• Strategic clinical leadership
• Clinical trial design and oversight
• Data interpretation and regulatory alignment
• Medical monitoring and site collaboration
• Regulatory documentation and medical writing
• Cross-functional collaboration
• Relationship building with KOLs and investigators

Education

• MD or DO with Oncology subspecialty; board certification or eligibility

Additional Requirements

• Work Location: On site (San Diego, CA)
• Work Authorization: United States (Required)
• Schedule: Full-time
• Relocation assistance may be available