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Medical Director, Clinical Development Santa Monica United States,  

Job Score (company)


Posted on : 02 December 2016

Project Description

We are a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient s own immune system to selectively target and kill cancer cells.  Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.  We are on a rapid growth trajectory and have a highly energized and accomplished team. We are publicly traded with a current market well over $2 Billion.

The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials.  Additionally, the Director leads the project teams to design and implement clinical studies at high quality and in a time- and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.  This position reports to the Vice President of Clinical Development.


Responsibilities include, but are not limited to:

  •  Provide medical monitoring to multiple oncology clinical trials  
  •  Lead project teams to design and implement clinical studies  
  •  Write protocols, investigator brochures, clinical study reports and review clinical trial documents  
  •  Conduct investigator meetings and lead site initiation visits with clinical trial investigators  
  •  Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets  
  •  Translate findings from research and nonclinical studies into clinical development opportunities  
  •  Interact with clinical investigators and thought leaders  
  •  Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines  
  •  Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner  
  •  Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs  
  •  Perform other duties as required  

Requirements:
 
  •  M.D. degree is an absolute requirement with board certification/specialization in Hematology or Oncology and experience managing oncology trials  
  •  At least 5 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience  
  •  Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies  
  •  Knowledge of carrying out  hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options  
  •  Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the company goals 
  •  Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators  
  •  Demonstrated ability to work well in teams in a cross functional manner  
  •  Ability to communicate and work independently with scientific/technical personnel  
  •  Ability to think critically, and demonstrated troubleshooting and problem solving skills  
  •  Self-motivated and willing to accept temporary responsibilities outside of initial job description  
  •  Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities  
  •  May travel up to 25%  

Locations

Santa Monica, Los Angeles County, California, United States

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