Senior Director of Clinical Operations - CRO

Posted 18 January 2023
Salary Competitive
LocationMassachusetts
Job type Full Time
DisciplineCRO & Clinical Operations
Contact NameValentina Narvaez

Job description

Mantell Associates is currently partnered with fast growing clinical stage Biopharmaceutical company based in Boston, MA, in their search for a senior director of clinical operations. 

Are you experienced in oncology and clinical operations?

Do you have a passion for helping people?

Are you looking for a place you can have long term growth?

This company has received $125 million in funding this past year and has made some recent acquisitions that is putting them way ahead of their competitors! They’re looking for a senior director that can manage challenges and navigate clinical operations in a way.

Senior Director of Clinical Operations Responsibilities:

  • Manage vendor relationships and develop ideal outsourcing model for delivery on clinical portfolio, such as oversight of CROs and other vendors

  • Spearhead strategic planning and the implementation of all clinical development programs globally

  • Develop, maintain, and report on program budgets, such as long-range forecasting and monthly accruals

  • Build process for and oversee medical writing, including contributing to and authoring documents such as study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and sections of regulatory submission documents

  • Create and maintain appropriate standard operating procedures (SOPs) and compliant management of clinical records

Director of Clinical Operations Requirements:

  • 7-10 years industry experience in all phases of clinical development

  • Oncology experience

  • Experience in managing vendors

  • Strong clinical operational experience for either a biotech or pharmaceutical company

  • Thorough knowledge of drug discovery and development program management, from IND- through BLA; as well as experience in preparation of clinical sections of INDs, BLAs/MAAs

 

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Valentina Narvaez at +1 786-485-1298 or valentina.narvaez@mantellassociates.com.