Vice President, Clinical Development

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.

• 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

• 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

Job Type: Full-time

Benefits:

·         401K

·         Medical insurance

·         Dental insurance

·         Vision insurance

·         Supplemental disability insurance plans

·         Flexible schedule

·         Life insurance

·         Flexible vacation

·         Sick time

·         Incentive stock option plan

·         Relocation assistance

Schedule:

·         Monday to Friday

Work authorization:

·         United States (Required)

Additional Compensation:

·         Annual targeted bonus %

Work Location:

·         On site (San Diego, CA)

EQUAL OPPORTUNITY EMPLOYER:

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.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.