Unum Therapeutics Inc. | 200 Cambridge Park Drive Suite 3100 | Cambridge, MA 02140  USA

Tel. +1.617.945.5576 | Email: info@unumrx.com

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Senior Clinical Trial Manager/Associate Director, Clinical Operations, at Unum Therapeutics

This is an outstanding opportunity to be a core scientist and scientific leader in a well-funded, early stage biotechnology company on the cutting edge of novel cancer treatments.

What benefits does Unum offer?
 

This is the inaugural position for Clinical Trial Management at the company.  As such, this individual will have the opportunity to come in and play a major role in shaping how Unum approaches Clinical Trial Management and Clinical Operations. 

 

Reporting to and working collaboratively with the VP, Development Operations, the successful candidate will be responsible for all aspects of clinical trial management for a novel T-cell therapy based approach for the treatment of cancer. Given the unique nature of the cell therapies we work on (both from a clinical and a production perspective), this role will provide lots of opportunity to make substantial contributions into a very complex and novel treatment paradigm.  

We are looking for someone who can bring significant capability to deliver on the operational needs of the role, while bringing a thoughtful perspective, drive for results, collaborative approach, and the ability to work with, influence, and communicate with a variety of stakeholders.

What are we seeking?

 

  • Project & Matrixed Leadership : Ability to lead projects and teams (internal and external) to deliver desired outcomes. High level of facilitation, detail-orientation, project management skills, and influencing strategy.

  • Strong, flexible and impactful communicator

  • Strategic and Analytical Thinking : Strong reasoning, detail oriented and creative problem solving ability is essential

  • Results Orientation : Self-motivated with the ability to drive exceptional results/outcomes, even with aggressive timelines.

What are other experiential requirements we are seeking?

  • BS/BA/RN Degree in science or a health related field is preferred

  • Minimum 6 years relevant industry clinical development experience; experience with complex therapeutic platforms and/or cell therapy clinical trials preferred

  • Experience with all aspects of trial and site startup and vendor management

  • Familiarity with clinical data review and data management processes, including Data Monitoring Safety Committees

  • Must be able to travel up to 20%, domestically and internationally

  • Excellent knowledge of GCP, ICH and FDA regulations

 

What will you be doing?

 

Responsibilities include study planning and execution, timelines, budget, and vendor management. You will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of Unum’s products.

  • Lead and coordinate clinical study management meetings

  • Manage trial budget and timeline

  • Train team members and site staff, including vendors, as needed

  • Participate in contract and budget negotiations with CROs, clinical sites and vendors

  • Develop critical study documents including informed consent forms, study conduct documents such as study manuals, the Study Operations Manual, study tools, etc.

  • Drive traceability procedures for investigational products and cross functionally coordinate patient treatment planning

  • Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed

  • Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, and motivational visits, as needed

What benefits does Unum offer?

 

To attract the very best talent, we are offering an extremely generous package that includes competitive pay, a performance-based bonus, stock options, health insurance coverage, trust-based time off, and commuter/parking benefits. Relocation assistance is also available to candidates who live outside of the Boston area.

Unum is an equal opportunity employer.
 

We are only accepting applications from candidates with authorization to work in the United States at this time.
 

Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.