Position: Medical Director
Report to: CMO
Location: Chengdu
Responsibility and Key Activities
?Accountable for the generation of development strategy study design and Clinical Development Plan via closely communication with KOLs/investigator
?Accountable for all medical related documents preparation at IND and NDA phase
?Working as drug development expert to lead and/or participate relevant medical activity.
?Ensures “best practice” in all activities and effective implementation and optimization of process improvements.
?Keeping vigilant on R&D advancement, acknowledging the guideline, academic progress and trends of the related therapeutic area, reading related reference/documents, attending academic conference.
?Accountable for the execution of all data-generating activities (studies) is compliant to ICH/GCP standards, Company SOPs, operating guidelines, legal and financial standards and practices.
?Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.
?Accountable for resource management, performance management and career development of medical team.
Education
?Clinical medical degree is a must.
?Master’s degree or Ph.D in Medicine or equivalent degree.
Experience and Knowledge
?M.D. with medical practice experience in Oncology (preferred) or similar therapeutic area.
?Comprehensive knowledge of ICH GCP, country regulations and all aspects of clinical operational management.
?Clear and accurate communication in written and spoken English.
?Familiarity with the therapeutic areas that are priorities for Company.
?Demonstrated ability to interact with different professional levels of the external clinical research community.
?Extensive (≥ 5 years) experience of all phases of clinical development, experience in Oncology drug clinical trial, from Phase I-III, is a must.
?Experience of line management of groups, including managing through others and leading high performing multi-functional study teams.
Competencies
?Highly motivated and collaborative, strong communication and interpersonal skills Scientific/Technical excellence.
?Strong ownership and team work spirit with the goal of project delivery.
?Can-do attitude and willingness to take challenge tasks.
?Critical thinking and Problem solving. Ability in working in a complex environment, managing multiple tasks and competing priorities simultaneously.
?Ability to work effectively in a changing environment.
?Must be able to manage their own work, highly organized, detail-oriented and able to multi-task with delivering high quality work under strict timelines.
?Decision Making- able to make sound decisions even in the face of ambiguous circumstances or contradictory requirements
?Teamwork and Collaboration- successful and comfortable working in a complex matrix, able to seek common ground in an effort to resolve conflicts, able to pull people together around a common goal, and to build diverse teams leveraging them to deliver exceptional results.
?Cost and financial awareness- good judgment in relation to trade-offs between cost and effectiveness.