Director or Sr. Director, Clinical Research Physician
Department: Clinical Science
Job Title: Director or Sr. Director, Clinical Research Physician
Report to: VP
Location: US
MAIN REPONSIBILITIES:
- Serve as the medical lead to provide medical input to the clinical development plan
- Contribute to the clinical development process including study feasibility assessment, study protocol development, and clinical study reports.
- Engage key opinion leaders and make scientific presentations at advisory boards
- Act as medical lead for assigned clinical trials or clinical programs
- Provide medical and scientific support to the clinical project teams
- Provide therapeutic area expertise to the clinical project teams
- Provide medical review of adverse events and SAEs
- Support pharmacovigilance in case processing and periodic reports
- Overseas medical aspects of the clinical trials risk management
- Interprets and communicates clinical trial data
QUALIFICATIONS:
- MD degree with more than 8 years of practicing clinical medicine
- More than five years of experience as Clinical Research Physician in the biopharmaceutical industry
- Experienced in planning and managing phase 2 and 3 pivotal clinical trials in oncology therapeutics area.
- Comprehensive knowledge of clinical development process and clinical trials methodologies
- Familiar with ICH GCP, and international regulatory requirements and guidelines
- Excellent communication skills
- Excellent interpersonal skills
- Strong problem-solving abilities
