TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Director, Clinical Development

Department :  Global R&D
Working place :  US
Recruitment :  3
Nature of work :  Full-time
Working years of :  5
Minimum academic :  Master
Release time :  23 Feb, 2022
Job Responsibilities
  • 1. Lead the clinical research team to formulate and implement the responsible product clinical development

  • plan. Ensure that the clinical development plan is in line with the clinical development strategy and

  • operation, and work with the clinical research team to provide estimates of the budget and resources

  • required for the implementation of the clinical research plan.

  • 2. Be responsible for or assist in the preparation and revision of clinical research project registration application

  • and clinical research related documents, including but not limited to clinical research protocol, investigator

  • manual (IB), informed consent form (ICF), CRF, research summary report (CSR), etc;

  • 3. In the process of clinical trial, be responsible for medical supervision and review of medical data, be

  • responsible for the training of clinical research scheme for researchers and project managers (supervisors), and

  • answer questions about clinical research scheme;

  • 4. Keep track of the latest progress and trends in the treatment field, collect and analyze industry and medical

  • information, and ensure professional and accurate evaluation of indications, medical practices, treatment

  • guidelines and published literature related to the company's research drugs.

  • 5. Be responsible for leading relevant clinical teams to formulate other clinical science related strategies or

  • plans, such as data analysis, interpretation, management of KOL and external clinical expert consultants in

  • relevant treatment fields, data / article publication, etc;

  • 6. Other tasks assigned by the superior.

Job Requirements
  • 1. Master degree or above (Bachelor degree requires clinical medicine as major); At least 2 years working

  • experience as a clinician is preferred;

  • 2. More than 5 years working experience in related treatment field or clinical research in pharmaceutical

  • enterprises or large CRO companies, such as clinical research, physician, medical manager, clinical project

  • manager, etc. working experience in medical science related to new drug clinical research in related treatment

  • field is preferred;

  • • Have an in-depth understanding of the knowledge and progress in relevant treatment fields,

  • be familiar with clinical experts in relevant treatment fields, and have a good

  • understanding of phase I-III new drug development.

  • 3. As a team leader, have good organization, communication, coordination, problem solving and leadership

  • skills, be creative and team spirit, and be able to work under pressure;

  • 4. Be familiar with the whole process of clinical research and understand the management norms of clinical

  • trials,

  • 5. Have good professional, official document writing and oral expression skills; Strong overall thinking, analysis,

  • judgment, decision-making and problem-solving skills;

  • 6. Skillfully use office software and be familiar with using the network to find professional and technical data;

  • 7. Fluent in English listening, speaking, reading and writing.