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地点：成都/北京

【Detailed Job Description】

- Assist in developing global clinical development plan for novel, investigational drugs from Phase I FiH trials all the way to registrational trials

• Primary focus on oncology (other indications such as autoimmune also relevant)

• Candidates for this position need to combine medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., oncology biomarkers and imaging, clinical pharmacology, biostatistics, etc.) to optimize the clinical development plan

- Writing and/or review of critical documents

• Synopsis, protocol, IB, ICF, etc.

• Responsible for the accuracy and integrity of these documents

  
  

- Oversight of medical tasks in clinical trials

• Responsible for anticipating and addressing various medical issues that may arise in clinical trials and from health authorities

• Manage interactions and answer medical questions from CROs, investigators, site staff

• Responsible for establishing working relationships with investigators, clinical sites, as well as regulatory authorities

• Make patient enrollment decisions, vetting inclusion and exclusion criteria, answer questions about procedures and concomitant medications, exceptions and exemptions, requests for waivers, etc.

• Review SAEs, assess causality and expectedness of SAEs, SAE narratives, SAE reconciliation, etc.

• Review of CSR

  
  

- Provide strategic medical guidance for the development of new oncology agents that are in preclinical development, when needed

-  Regularly participate in meetings with CROs, when needed

-   Attend Medical Conferences and Meetings, and work on manuscriptpublications

- Participate in weekly clinical team project & strategy review meetings

 

【Education Requirements】

-  MD degree required, oncology specialty is preferred

 

【Language Requirements】

-    Fluency in English (oral and written)

 

【Experience/Professional Requirements】

-   Extensive priorindustry experience in oncology clinical trials (medical monitoring, clinical development, medical advisory) at reputable biopharmaceutical companies and/or CROs

• Must have extensive oncology / immuno-oncology experience;

• Proven ability to analyze and interpret efficacy and safety data;

Extensive medical writing experience (protocol, IB, publications, etc.);

• Capability to interpret preclinical data in oncology (molecular biology, pharmacology, PK, toxicology, etc.);

• Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials;

• Knowledge of GCP and global regulatory requirements;

• Effective written and oral communication skills;

• Excellent personal ethical integrity and a commitment to improve the outcomes for patients
  
  
  职位联系人
  
  

  Kerwin Huang（黄凯）

  Tel: 028-86703896  

  Mobile: 13551832040 

  Mail: kerwin.huang@isaac-kenneth.com