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Location
Boston
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-19271
Contact
Tom Tan
Contact email
Email Tom
Posted
大约 3 小时 前
AI-driven drug discovery biotech with teams across Asia, UAE, Europe, and North America. They are on the lookout for a Clinical Development Head to be based in Greater Boston area (hybrid).
 
Responsibilities:
  • Development of clinical documents such as protocol/amendment update, IB update, annual study report, etc;
  • Contribute to regulatory activities such as IND, NDA submission, and data cleaning activity;
  • Clinical interface for other functions for successful delivery of study;
  • Review SAE’s and safety data, ensure all relevant parties are notified and the company is compliant;
  • Present the Medical and Clinical strategy to internal and external stakeholders
  • Build relationships to gain market advantage including thought leaders and principal investigators;
  • Drive development of clinical strategy for products across pre-clinical development, clinical research, and regulatory affairs;
  • Ensure all clinical trials are executed on budget and within strict timelines;
  • Vendor management – Identify suitable vendors, delegate vendor responsibilities, develop vendor reporting procedures and plan of action;
  • Reports directly to CMO;
 
Requirements:
  • MD (medical oncologist, or industry trained in oncology and/or immune-oncology or hematology);Experience in clinical trial oncology area for several years;
  • Experience in Pharma industry for a number of years;
  • Knowledgeable in science of oncology and able to analyze the data;
  • Excellent interpersonal skills
  • Ability to work in a diverse environment with different stakeholders;
  • Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities;



BeathChapman Pte Ltd