Director/Sr. Director of Clinical Development Operations

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Cambridge, MA
$1 - $1
Job Type
Direct Hire
Nov 15, 2018
Job ID
The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs.  Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial Managers and/or other operations personnel. Partner with the VP Clinical Development Operations to institute effective and efficient procedures and vendor partnerships.
Key Responsibilities: 
  • Develop, lead and manage clinical operations activities for one or more clinical programs; mentor and leverage internal resources; optimize CRO and vendor expertise and resources to delivery clinical studies according to program needs. Collaborate with cross functional program level leads to ensure operational plans for clinical studies are in line with program level goals.
  • Provide strategic input in to clinical development plans and develop operational strategies to meet program needs across multiple studies.
  • Along with VP Clinical Development Operations evaluate, implement and leverage appropriate outsourcing strategies for one or more clinical programs. Ensure appropriate connections among studies of the same program or similar indications.
  • Manage and mentor study staff to develop protocols and study level operational plans, oversee the execution of studies by vendors, and deliver studies to quality, time and budget goals. Provide guidance and support to study leads in the set up and management of CRO and vendor management and the day to day operational activities.  Ensure appropriate timeline tracking systems are in place to support risk assessment and mitigation.
  • Ensure robust data quality approaches are in place for all studies across one or more clinical programs that support enrollment of the right patient population and accurate end point data. Partner with biostatistics, medical and other functions in regular data reviews, identify and implement corrective actions or improvements.
  • Develop program level country selection and site identification strategies. Oversee study staff to implement strategies for each study. Monitor study level risk management activities and ensure risk mitigation plans are in line with program needs.
  • Partner with Medical Affairs to develop program wide approaches to recruitment, advocacy, Key Opinion Leaders, Steering Committees, etc.
  • Interface and communicate with stakeholders with across functions (program management, regulatory, legal, finance, commercial, etc.). Budget forecasting and management oversight for all studies across program(s).
  • Identify and implement process improvements within Clinical Development Operations and across Development. 
  • At least 12 years of clinical operations experience with a Biotechnology/Pharmaceutical company leading Phase I - IV multinational clinical studies. Additional experience with a CRO is a plus and may be considered part of the clinical operations experience.
  • Clinical development plan and protocol development experience as well as program and study level operational strategy experience is important.
  • Strong regulatory knowledge including but not limited to Good Clinical Practices (GCPs), ethics requirements for protection of human subjects, multi-national considerations for clinical operation plans.
  • Line management and team mentorship skills.
  • Strong project management and multi-functional team leadership skills.
  • Excellent communication skills (written and verbal, including presentation skills) and ability to effectively interface with senior leaders within and external to the company.
  • Travel 10-20%.
  • Bachelor's Degree is required, preferably in a scientific/clinical discipline. An advance degree in scientific, clinical research or regulatory affairs, or business/finance is preferred.
  • Previous rare disease clinical operations experience is preferred.