Clinical Operation, Senior Director/Executive Director

Responsibilities

  1. Responsible for the planning, implementation, operation and management of clinical trials;
  2. Establish and maintain a good cooperative relationship with clinical centers and PIs, and explore and expand cooperative hospitals and PIs according to the company’s development needs;
  3. Follow up the completion of each stage of the project, track the implementation of the clinical trials, find and solve problems in time, and ensure the quality and progress of the clinical trial;
  4. Managed the CRA team，be responsible for the construction and training of the team;
  5. Follow up the updates of relevant policies and regulations such as NMPA, FDA and EMA, ensure that clinical trials are conducted in strict accordance with regulations, ICH-GCP and SOPs, and complete clinical trials in accordance with the plans and quality requirements；
  6. Responsible for the management of third-party suppliers during the project implementation （such as CRO, SMO, Central lab，etc）
  7. Responsible for the evaluation and selection of clinical center, clinical contract negotiation and management；
  8. Responsible for management of team members, arrangement of employees’ work, regular communication with employees and evaluation of their work performance; effective department team building, etc.
  9. Timely feedback to the CMO, CEO about the project, personnel and problems encountered and propose solutions.

Requirements

  1. Bachelor’s degree or above in clinical medicine or pharmacy related majors;
  2. 15+ years of experience in drug development clinical operation related work, familiar with the current status and development trend of oncotherapy, experience in oncology field (especially intratumoral drug delivery) is preferred;
  3. Strong knowledge of ICH guidelines, FDA, NMPA clinical trial related regulations and guidelines;
  4. Rigorous work, good project management experience; excellent leadership skills, communication skills, stress tolerance and teamwork ability.
  5. Good English communication skills, reading and writing skills.