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Sr. Director, Clinical Operations, Rare Disease

Cambridge, MA

Posted: 07/25/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2372

Our client is seeking a Sr. Director of Clinical Operations to design and lead clinical operations initiatives across projects as well as manage external contractors and CROs. Reporting directly to the client’ s Head of Therapeutic Operations, this position will work collaboratively across several therapeutic area teams for clinical operations activities of individual development programs.

Overview:
  • Study Management of first-in-human and early phase clinical trials of development candidates.
  • Manage cross functional leadership and CRO/vendor management related to clinical trial operations aspects.
  • Lead in the selection and oversight of CROs and other vendors
  • Develop and lead the review of clinical outsourcing strategies and plans
  • Manage assigned clinical trial budgets
  • Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
  • Initiate and lead monitoring oversight activities are conducted in accordance to client  and ICH/GCP standards
  • Along with other Clinical Development personnel, represent the Company externally to Investigators and trial site administrators
  • Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
  • Maintain oversight and participate in the review of departmental SOPs to ensure compliance
  • Develop and maintain strong, collaborative relationships with key stakeholders 

Requirements:
  • At least 10-15 years of global trial management experience in a clinical research environment, most of which should be in industry and with global trials
  • Advanced degree preferred or Bachelor’ s in a science-based subject
  • Cross therapeutic experience including infectious disease or vaccine trials
  • Solid experience in early phase drug development and proven track record of success
  • Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
  • Cross Collaboration proficiency with other functions such as Research, Drug Supply, and Finance.
  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world 
  • Experience in regulatory GCP inspections/audits
  • Outstanding verbal and written communication skills including clinical authoring experience including protocols and investigator brochures
  • Excellent organizational skills and ability to work independently
  • Proven track record of effective leadership in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
  • Creative, capable problem-solver
  • Experience in establishing and maintaining relationships with key opinion leaders

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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