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.

In Vivo Scientist (Pharmacology)

Responsibilities

  1. Contribution to planning, design and execution of in vivo pharmacology studies aimed at building pharmacologic relationships between drug exposure, target engagement, pharmacodynamic biomarkers, and activity of company molecules;
  2. Contribution to Ex vivo analysis of tumor or immune cells from various tissues, including collection and processing of multiple tissues and analysis, cell phenotype and functionality using multicolor flow cytometry and ELISpot would be a plus;
  3. Design and establish murine tumor models;
  4. Perform in vivo procedures in mice, including preparation and administration of dosing solutions via intravenous, intraperitoneal, and subcutaneous dosing routes, etc. and measure/readout of tumor progress;
  5. Effectively document study details, analyze and interpret data, and clearly communicate results within the organization;
  6. Collaborate with CROs and academic partners to generate data supporting preclinical development of company molecules;
  7. Work collaboratively with members of cross department team member to achieve team goals and support organizational goals.

Requirements

  1. B.S. or B.A. degree in biological science or equivalents with 3-5+ years of relevant research experience, and a track record of delivery within in vivo pharmacology;
  2. Hands-on conduct in vivo techniques involving rodent models of tumor, delivering novel therapeutics;
  3. Pharmacokinetic and pharmacodynamic analyses, clinical observations, and harvesting of tissues for analysis of efficacy;
  4. Prefer to have knowledge of mouse models of tumor biology and inflammation, animal care and use procedures;
  5. Prefer to handle standard molecular biology techniques to evaluate therapeutic effect (such as, but not limited to, RT-qPCR, ELISAs, and Western blots, tissue processing, FACS-based phenotyping, and functional analysis of immune cells using multicolor flow cytometry and ELISpot);
  6. Scientifically rigorous, highly organized, with significant attention to detail;
  7. Self-motivated, team- and goal-oriented scientist with good oral and written communication skills;
  8. Enjoys working in a fast-paced, small-company environment as part of a collaborative team.

Research Assistant

Responsibilities

  1. Actively cooperate with superior leaders and the company’s internal and external scientific research cooperation communication to promote the smooth progress of scientific research projects;
  2. Manage the reception, statistics, sub-packaging, and delivery of scientific research samples within the company; be responsible for the management of the reception, classification, storage, statistics, and filing of scientific research materials and documents;
  3. Read the cutting-edge literature of the biomedical industry to achieve self-improvement, and share and report when necessary;
  4. Assist the company in applying for projects and undertake part of the research project writing work;
  5. Other matters arranged by supervisors.

Requirements

  1. A full-time master’s degree in biology, chemistry, cell, and medical related majors, fresh or above to 2 years of work experience are acceptable, and those with better English are preferred;
  2. Have good learning ability, adapt to the efficient style of the Internet industry, and have a strong ability to withstand pressure;
  3. Be careful in work, have good communication and work habits, be stable, careful and cautious, have a high sense of responsibility, have strong coordination, communication skills and teamwork spirit;
  4. Focus on image, have strong writing and language communication skills and interpersonal relationship processing skills, be able to be flexible; have excellent logical thinking ability and execution ability.