Jobs at Cogent Biosciences (Now Hiring) — 15 open

• • Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations. Provide strategic oversight of CROs and vendors, ensuring accountability, quality, and operational execution. 
  • Develop and review study performance metrics and drive corrective and preventive actions when needed. Evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review clinical data. 
  • Develop strong partnerships with external stakeholders while maintaining sponsor ownership of study execution. Serve as Clinical Operations representative on Strategy Teams, and coordinate and lead study team meetings and update the cross-functional Team on timelines and milestones for the study.  
  • Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, and ensure proper team and external training. 
  • Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing. 
  • Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors 
  • Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as needed 
  • Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house. 
  • Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs. 
  • Limited travel possible to clinical sites for investigator and site engagement, with potential to travel  (~25%). 

Qualifications:

• • BS/BA Degree or equivalent in science or a health-related field is preferred 
  • Minimum 6-7+ years of relevant industry clinical development experience  
  • Experience with complex therapeutic platforms  
  • Multi-phase clinical trials  
  • Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring 
  • Familiarity with clinical data review and data management processes 
  • Excellent knowledge of GCP, ICH, and FDA regulations 
  • Experience with SOP review and development 

Salary Range:

$185,000- $215,000USD