HUTCHMED

Career Opportunities

Job Title:	Associate Director, Clinical Research Physician
Location:	Shanghai

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

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

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

Job Title:	Clinical Project Manager
Location:	Shanghai / Beijing / Guangzhou / Nanjing / Hangzhou / Suzhou / Tianjin

Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
Input operational part of the protocol for trials.
Review and approve study CRFs.
Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
Contact with CMC department regarding design of labeling, packaging and drug logistics.
Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
Select clinical trial site and keep good relationship with investigators.
Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
Support contract negotiation with study sites.
Select and cooperate with statistician to conduct data analysis when required.
Participate in regular Data Quality Review Meetings.
Coordinate final trial report.
Support CRO Selection.
CRO supervision at the trial level.
Support IND and NDA filing: Document review and progress tracking.
Do co-monitoring visits for the project.
Review monitoring reports.
Check TMF before archiving.

At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
At least 3 years industry experience with proven proficiency in clinical research management for drug development.
Good understanding of ICH guidelines, GCP and regulatory requirements.
Excellent planning, organization and problem solving abilities.
Good communication and interpersonal skills.
Proficiency in English and familiarity with standard IT office tools.

If interested, please forward your resume to KellyL@hutch-med.com

Review product registration dossier and relevant documents
Obtain IND & NDA approval as well as product registration license renewal as planed
Coordinate with each function within HMPL from registration pathway
Establish and maintain relationship with external stakeholders
Liaise with external stakeholders for regulatory needs of HMPL
Implement regulatory activities as required by governmental regulations and internal SOPs
Form accelerate Strategy for product registration

Qualifications