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
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.
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
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
Excellent English (writing and speaking) and excellent mastery of English medical terminology