Medical Director/Senior Medical Director - (KRAS G12C)
This is a newly created role, with the primary focus on the KRAS G12C Inhibitor program (MRTX849). The molecule is currently in phase I but is anticipated to move into a broad range of studies defining efficacy of both monotherapy and combinations. There will also be the opportunity to support selected aspects of the Sitravatinib program which is currently in pivotal lung cancer studies and a range of exploratory studies in other tumor types.
The successful candidate will have a passion for novel science, an affinity for strategic thinking, looking beyond the day-to-day execution, and will have a track record of keeping clinical programs on track and hitting milestones. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the program to regulatory standards and procedures and will be graded according to the level of experience of the successful candidate
- 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
- 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)
- Provide direct management, leadership and mentoring of other Clinical team members
- Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
Position Requirements & Experience:
- Medical Doctor (M.D.), either with Board Certification in Medical Oncology/ Hematology Oncology or Internal Medicine
- Minimum of (5) years of clinical development experience in the pharmaceutical or biotechnology industries.
- Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
- Phase I-III oncology clinical trial experience preferred, with emphasis on serving as the medical leader for trial programs.
- Working knowledge of the IND/NDA process preferred.
- In-depth knowledge of GCP/ICH guidelines preferred.
- Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
- Available for ~ 25% travel, including overnight stays.
Personal Characteristics & Cultural Fit:
- Strong written and verbal communication skills required.
- Ability to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities.
- Executive leadership skills including a collaborative and team-oriented approach.
- Good organizational, time management and interpersonal skills.
- Demonstrated excellence in management skills, with track record of successfully managing multiple projects, trials, and priorities.
- Ability to work well with global, multi-disciplinary teams.