Clinical Operations Senior Manager/Associate Director/Director

Pathos was founded to revolutionize precision medicine in cancer by harnessing the power of machine learning to transform drug development. Pathos aims to accelerate traditional oncology approaches based upon a comprehensive and integrated data-first strategy to discover and develop drugs for precise biological pathways. Pathos is currently pursuing co-development and in-licensing opportunities to build a portfolio of clinical stage oncology assets, applying its technology to find the right patients and indications, resulting in a highly improved probability of success and faster time to market.

The founding team built and scaled Tempus Labs, an AI-enabled diagnostics company that has built the world’s largest library of clinical and molecular data and an operating system to make sense of it. Through this experience, the founders have seen how precision medicine can transform lives, yet many patients remain who need better therapies. A new approach is needed to change the paradigm of drug development to rapidly serve these unmet needs, highlighting a unique opportunity for Pathos to pursue. We’re looking for other trailblazers who see the world differently and want to forge this new path with us.

Our team is distributed across the US with hubs in New York and Salt Lake. While we still operate with the agility of a startup, we are scaling to advance our platform. 

About the role


The Role

 

We need an Associate Director of Clinical Operations to help us achieve several key objectives, including:

Supporting and overseeing the execution and delivery of Pathos clinical trials with a focus on quality, safety, data collection, timelines, applicable regulations, and safety.  The Associate Director, Clinical Operations will be responsible for the management (planning, implementation, maintenance, and close-out) of Pathos’ clinical studies.  


Associate Director, Clinical Operations participates in program design and supports the development and execution of operational plans in alignment with the company’s strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice (GCP). Director, Clinical Operations is responsible for effective development and management of relationships with external team/vendors including investigators, CROs, consortia, central labs, IRB, and other internal and external partners. 


Additional Job Responsibilities include:

  • Provide strategic input to clinical development programs including various clinical study scenarios and associated risks and costs. 
  • Provide input to study designs and protocols to ensure operational success and clarity for CROs and/or clinical sites.
  • Responsible for the delivery of the project(s) within a portfolio to achieve agreed timelines, scope, quality, and budget. 
  • Provide timely and accurate input to clinical development plans including forecasting of timelines, assessment of feasibility for protocol design, estimation of resources required, and management of project level budget. 
  • Oversee development of operational plans to ensure compliance to current regulatory guidance and GCP. 


Who you are


Ideal candidates will bring deep technical expertise in clinical and study operations, as well as early phase oncology.   


  • Bachelors degree required and Masters/higher strongly preferred.  
  • Minimum 10 years of clinical research experience needed. 
  • Minimum 3 years of study management experience.  


Clinical

Remote (United States)

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