Remote, CA 92121 US
The Medical Director will act as a subject matter expert in Clinical Development providing medical and clinical leadership and oversight for Phase 1? 3 oncology clinical trial(s) as described in the responsibilities below. You will be responsible for being a single point of accountability for the clinical trial(s) you lead, effectively collaborating with external (eg, Investigators, regulatory agencies) and internal key stakeholders towards successful study implementation.
- Clinical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements.
- Help identify global study sites and foster relationships with study investigators
- As the primary medical monitor for assigned study(ies), be the first point of contact with sites; answer site questions about eligibility, enrollment; safety and patient management
- Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues
- Production of clinical documents required for the conduct of clinical studies, such as clinical protocols (and amendments as needed), informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices
- Preparation of abstracts and posters for scientific meetings
- Preparation of slides / presentation at internal and external meetings, such as team meetings, Advisory Boards and Board of Director Meetings
- Lead ongoing data interpretation to understand safety and efficacy profile of the investigational drug
- Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
- Present aspects of clinical program at Site Initiation Visits, Investigator's Meetings and scientific conferences
- Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas
- Assist in case report form (CRF) development and data analysis plans
- Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
- Perform in data cleaning and clinical study report review
- Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study reference manuals
- Assist in generation and update of Clinical Development Plan (CDP)
- Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
**CO candidates may not be considered
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