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Janux Therapeutics · 7 hours ago

Vice President, Clinical Development

San Diego County, CA

Full-time

Onsite

Director/Executive

$350K/yr - $440K/yr

8+ years exp

Janux Therapeutics is seeking a Vice President of Clinical Development to serve as the strategic clinical lead for their IND programs and ongoing clinical trials. The role involves providing oversight and direction for clinical trial programs, leading the design and implementation of clinical strategies, and ensuring alignment with regulatory requirements.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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, 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 KOL’s, medical experts and investigators in the area of Immuno-Oncology and more importantly, within the genitourinary disease areas

Other duties as deemed essential

Qualification

Oncology MDDOClinical trial leadershipEarly drug developmentGCPICH guidelinesData evaluation skillsCommunication skills

Required

MD or DO with a subspeciality in Oncology, more specifically in the treatment of genitourinary cancers is 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 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