AD, Clinical Research Physician

PRIMARY FUNCTION/主要职能

• Be responsible for the strategy and clinical development of clinical development line function by managing a group clinical research physician(s)
• Take lead in Clinical Development Activities related to products, protocols or studies, timeline and budget
• Provide leadership on project teams as clinical project leader
• Serve as a scientific, medical accountable person for quality and timely delivery
• As the primary development physician, represent the company while interacting with health authorities

MAJOR RESPONSIBILITIES, AND DUTIES/主要责任和职责

• Establish and maintain liaisons with KoLs and principal investigators
• Accountable for clinical and regulatory documents; ensure clinical trial design is scientific sound as well regulatory viable
• Ensure high quality and completeness of clinical and regulatory documents, including but not limited to clinical study protocol, scientific paper publication, clinical study report, etc. Ensure project timelines are met.
• Responsible for managing study and program costs/timelines against agreed-upon plans
• Provide scientific/strategic input to licensing and business development opportunities, including early phase development aspects
• Completes tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience
• Supervise and lead the study conduct and assure that results meet the high standards of quality
• Serve as a key knowledge source for internal stakeholders including Country Medical.
• Represent the client through contact with Health authorities, KOL, Universities, and CROs
• Participate and interface with the publication strategy team.

Qualifications/资质

• A MD level is mandatory
• At least 5-year experience in oncology clinical development
• Must have experience and/or solid understanding of all levels of clinical development (Phase I-IV)
• Must have experience with the planning and execution of strategies for drug product registration, development and life-cycle management
• Demonstrated ability to understand and manage, with appropriate support, the resources, time, and budgets for assigned projects
• Ability to develop network internally and externally to effective communicate in situations requiring special tact and diplomacy
• Excellent English (writing and speaking) and excellent mastery of English medical terminology