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Medical Director

3 months ago

Cambridge, United States QurAlis Full time

ABOUT THE COMPANY  

At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.   


SUMMARY OF POSITION 

Reporting to the CMO, in this newly created position, we are seeking a motivated experienced Quralis Medical Director.  


Primary Job Responsibilities:  

  • Support clinical programs (up to 2) by developing and/or contributing to, with a cross functional team, Clinical Development plans and study protocols 
  • Participate in clinical trial team meetings (internal and external) for both ongoing studies; help with planning and development of future clinical trials 
  • Responsible for oversight of CRO medical monitor(s); provide medical expertise on ALS and our investigational product; ongoing risk: benefit evaluation, at a study, program and portfolio level  
  • Contribute and review (medical and safety expertise) in the development of Informed Consent Forms (ICFs), Case Report Forms (CRF), CRF completion guidelines and edit specifications, statistical analysis plan (SAP), Serious Adverse Events (SAE) forms and reports (assist with risk: benefit review), and more 
  • Participate in ongoing, QurAlis led, data reviews 
  • Engage with study Investigators (the Sponsor voice) and program/ALS KOLs 
  • Other medical/clinical development activities, as identified by the CMO and/or clinical trial team 

 

Primary Job Requirements:  

  • MD with Board Certification in a relevant discipline such as, internal medicine, neurology etc. 
  • Subspecialty Endocrine/GI/Renal, a plus 
  • Combination of at least 5-10 years of clinical academic research and/or 3-5 years industry drug development experience (neuromuscular diseases such as ALS a plus, but not necessary) 
  • Experience designing, and developing, or overseeing others in design and development of clinical studies and cross-functional initiatives 
  • Willingness to work in new drug development areas 
  • Strategic/creative thinker/results oriented 
  • Excels in a multi-project, fast-track team-oriented environment. 
  • Strong interpersonal, communication, influencing, problem solving, skills