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(Senior) Clinical Research Scientist
Position Type: Full-time
Location: Rockville, MD
Immediate Supervisor: Senior Medical Director/ Medical Sciences/Chief Medical Officer
Summary: The Clinical Research Scientist is responsible for oversight of a single or several smaller clinical development programs, a single complex/novel study such as platform or basket trial, or as a member of the medical science team for a global trial, with primary responsibilities for drug development in clinical sites outside of China. The scope will differ depending on the exact nature of the clinical program. The Clinical Research Scientist also provides expert input to improvement projects to enhance the overall clinical development program.
- Evaluate pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications;
- Provides advice on clinical development strategies for investigational drugs for treatment of cancer at clinical sites outside of China (primarily in the U.S. and Europe) in the context of the overall global development program; closely coordinates with peers in China on global development strategies; and reviews and assesses new information on competitive drug development to assess risks to development strategies and integrates emerging data into drug development plans;
- In conjunction with CMO and/or Senior Medical Director, liaises with the internal and external medical community (e.g., Key External Experts (KEEs), Key Opinion Leaders (KOLs), Advisory Boards) to follow developments within assigned therapeutic area(s);
- In conjunction with CMO and/or Senior Medical Director, designs clinical trials (study design, clinical operation plans, exploratory biomarker assessments) for the US and globally, based on the proposed clinical development strategies;
- Provides input in therapeutic area(s) for project or study level documents, including but not limited to the clinical development plan, clinical study protocol, and clinical study reports to ensure compliance with GCP and applicable regional regulations as well as ensuring the scientific integrity of individual studies and the development program;
- Monitors and manages the conduct of clinical trials for investigational drugs for the treatment of cancer outside of China (primarily US and Europe);
- Develops strategies for, or drafts initial regulatory response to, complex technical issues for specific medical aspects on current projects, new projects and the broader therapeutic area; leads medical aspects of regulatory communications (written and verbal) for investigational drugs and marketing applications.
- Conducts analyses of efficacy, safety, and biomarker data from clinical studies to support clinical protocol modifications or other decisions throughout the development program and summarizes clinical findings in support of investigator/safety review committee meetings, clinical study reports, new drug or biologics license applications, and publications;
- Participates in research project teams on the development of investigational drugs and the further study of marketed drugs.
- Works closely with a cross-functional group of experts in regulatory affairs, clinical operations, statistics, clinical pharmacology, translational assays, nonclinical toxicology and manufacturing, as appropriate, to manage clinical development projects. Coordinates with counterparts in China on global clinical development programs. Assists the Senior Medical Director in ensuring that appropriate company personnel are informed of the progress of studies for TopAlliance and of competitors’ drugs. Provides internal and external input and recommendations on scientific questions relevant to his/her areas of responsibility.
- Authors detailed development documents, presentations, and position papers for internal and external audiences
- Facilitates collaborations with external researchers
- Participates in conference calls approximately up to two times per week that may occur outside of normal business hours and may travel up to five (5) percent of the time to manage future or ongoing clinical research projects.
- M.D. or M.D./Ph.D.
- Minimum of 3 years of clinical medicine experience
- Minimum of 3 years of experience in the field of drug development or biomedical research
- Strong interpersonal skills, as well as the ability to function in a team environment are essential.
- Prior specific experience in the conduct of clinical research studies, including preparation of documentation for and presentation to, regulatory health authorities
Please email a cover letter and resume to email@example.com, attn: Emily Xu