Job description
Senior/Executive Director Clinical Operations – Boston, Massachusetts
Mantell Associates have partnered with a cutting-edge Global biotech who are experiencing an incredible growth period following exceptional results and a surge of investment ($100+ Million). They are currently looking to strengthen their Clinical Operations team through the appointment of a Senior/Executive Director Clinical Operations to work closely with the Chief Medical Officer and Chief Executive Officer
Responsibilities
· Provide leadership & strategic oversight to ensure resourcing and budgeting goals are met
· Line management of Clinical Operations team to ensure timelines and deliverables are met
· Integration of clinical operations knowledge and expertise to various cross-functional teams/divisions
· Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee and Project Teams,
· Lead & mentor Clinical operations staff to support successful internal training
· Work closely with the CEO & CMO to provide oversight and strategic development within the Clinical function
· Build and maintain effective relationships with Investigators, KOLs, patient advocacy groups, regulatory agencies in implementation of study protocols, collaboration on feedback, etc.
Requirements:
· Minimum 10 years Clinical Research experience, 5years+ global study experience
· Previous experience working within a Pharma or Biotechnology environment, (CRO acceptable)
· Oncology is desirable
· 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
· Highly organized and detail-oriented, with the ability to keep multiple projects and client engagements active at once.
· Exceptional verbal and written communication skills.
· Independent critical thinking and creative problem solving skills.
Mantell Associates is a specialist Pharmaceutical and Life Sciences Executive Search organisation. For more information on this role, contact Lewis Davis on +44 (0)20 3778 0990 or lewis.davis@mantellassociates.com