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Senior or Executive Medical Director
4 months ago
The Senior or Executive Medical Director will be tasked as the clinical lead for one or more of Janux's newer IND programs and/or ongoing clinical trials in solid tumors or hematologic malignancies. The ideal candidate will have clinical experience in oncological diseases and a proven track record of success leading clinical trials within academic, biotechnology and/or pharmaceutical industries. Said track record must include the development of clinical trial strategy and tactics, interpretation of clinical trial data, medical monitoring of early phase clinical trials, and positive and productive interactions with industry KOL's, medical experts and investigators.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: The Senior or Executive Medical Director will be asked to:- Serve as the clinical development lead and source medical expertise for one or more clinical trial programs
- Partner with Pre-clinical R&D, Clinical Operations, Regulatory Affairs, Quality Assurance and Senior Management to formulate and implement strategic clinical trial plans
- Perform the duties of a Medical Monitor to ensure clinical integrity and safety accountability
- Serve as medical support for investigative sites and clinical project staff
- 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
- 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 KOL's, medical experts and investigators in the area of Immuno-Oncology
- Other duties as deemed essential
- MD or DO with a subspeciality in Oncology is required
- Successful completion of post-graduate training or residency in Oncology, along with board certification or board eligibility is highly desirable
- Minimum 5 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
- Strong ability to critically evaluate data, literature, and presentations
- High level of communication skills is expected
- 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
- Monday to Friday
- United States (Required)
- Annual targeted bonus %
- On site San Diego, CA
