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

 

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 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

 

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

 

Primary Function

  • Management of clinical research project.
  • Vendor (CRO, Lab, drug storage, etc.) supervision and management.
  • Liaison with KOLs.
  • Support IND and NDA filing.
  • Quality control of the clinical research projects, such as co-monitoring.

 

 

Responsibilities

  • 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.

 

 

Qualifications

  • 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

Responsibilities

  • 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

  • Bachelor degree and above in Pharmacy or Pharmaceutical
  • 5 years or more drug registration experience in pharmaceutical industry
  • Prefer oncology drug registration background
  • Good understanding of Chinese pharmaceutical & regulatory environment
  • Good relation with stakeholders related to product registration
  • Fluent English
  • Strong communication skill
  • Passion in drug development