Apply: Therapeutic Area Head, Oncology/Hematology (Clinical Develop...

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