Job Description：

1.Therapy Area Expertise

–Act as senior technical/medical expert for oncology/haematology products in development and medical support activities.

–To exhibit a high level of knowledge on medical and development when working with other function lines like Drug Regulatory Affairs, operation and commercial.

2.Logistics Support.

–To alert local teams of advances and new data from global sources.

–Ensure and oversee the scientific quality of presentation and publications made by China Development team members.

–Lead and manage the China Project Team (CPT) to meet the specific development timeline and to ensure maximum efficiency in new drug development and registration.

–Undertake specific additional projects related to clinical development as may be required by the Clinical Development head from time to time

3.Clinical Development

–Timely catch up with and understand development plan and progress. Understand China clinical needs, practices and environment to perform evaluation on how pipeline opportunities, risk & benefits are in China.

–Lead clinical strategy development, oversee clinical projects plan. The CD manager is expected to manage multiple projects/ ongoing work activities of high complexity within their own business line or sub-function.

–To Lead and direct a cross-functional Project Team - the China Project Team (CPT) to assure the successful establishment of new drug development and registration strategy, which meets the specific development timeline and also ensure maximum efficiency. During the CPT practice, the CDP demonstrates extensive industry knowledge when perform tactical assessment of country capability, disease prevalence, treatment guidelines, competitive landscape, business interest; medical availability etc to aid appropriate placing of studies. Provide input into appropriate prioritization of studies, consistent with local and regional strategy, balancing the short term and long term local business needs.

–Develop and leverages resources to implement the development of appropriate clinical trial protocols, synopsise and summaries to support development strategies.

-Discuss protocols with KOLs, global teams and local DRA and partner

-Ensure input into Development plans from Medical Affairs and marketing functions especially around planning for optimum approved label.

-Provide strategic input to publications/publication plans of clinical trials for registration, supervise writing, write and review abstracts, manuscripts for presentation/publication at internal/external meetings.

-Clinical Trial Application [CTA] and New Drug Application [NDA] clinical dossier support and preparation including CSR preparation

-Prepare, attend meetings and interact with Health Authority at specific meetings or on ad hoc basis. Provide expertise to cross-functional groups in preparations for HA interactions.

-Make decisions regarding eligibility, enrolment and data consistency.

-Contribute to the ongoing scientific review of the clinical trials.

Requirement：

–Medical doctor with clinical experience and preferably post-graduate degree in the field of oncology/haematology or related biomedical field.

–Significant training/experience [at least 2 years] in clinical development in the pharmaceutical industry or equivalence

–Track record of scientific achievements in clinical research

–Advanced Medical/scientific and state-of the art clinical research knowledge in oncology/haematology

–Familiar with all aspects of the drug development process

–Expert in clinical trial design.

–Proven ability to interpret, discuss and represent efficacy and safety data in the oncology/haematology field.

–Advanced medical/scientific writing skills

–Superior English writing, reading, speaking and listening skills and attention to detail

–Strong communication skills within a multidisciplinary team and in interfaces with other departments and headquarters

–Strong Sense of responsibility and dedication

–Teamwork spirit

–Skilful at Word/Excel/Access/PowerPoint/Microsoft project.