Job Description:
• Facilitate generation of, author, update, and/or review key documents
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
• Provide scientific expertise for selection of investigator and vendors
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout conduct of a clinical trial
• Review, query, and analyze clinical trial data
• Create clinical study or program-related slide decks for internal and external use
• Build and maintain opinion leader/investigator networks
• Identify continuous process improvement opportunities
• Support budget planning and management
Requirements:
• 6+ plus years of experience and success within other biotech/pharmaceutical companies
• MD or DO or international equivalent degree required
• Previous participation in a clinical development program is essential
• Minimum 3 years relevant work experience in oncology clinical development
• Experience in conducting lung Cancer clinical trials strongly preferred
• Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing
• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
• Knowledge of GCP and ICH Guidelines
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel approximately 25%
• Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred
• Experience with the development and support of related SOPs and policies is expected
• Knowledge of industry standard Clinical Development IT solutions expected.
Benefits:
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness