PRIMARY FUNCTION

● 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 hematologic malignancies 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

● Manage and train clinical project leader(s) and clinical research physicians
● 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 for the company goal and requirement
● 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

● 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
● Experience of leading teams
● Excellent English (writing and speaking) and excellent mastery of English medical terminology