Senior Consultant - Clinical Development

Boston
 

Halloran is looking for a motivated Clinical Development professional to join our team. The successful candidate will have a proven record of clinical development experience within biotech and/or pharmaceutical companies with deep subject matter expertise in clinical trial management and program level responsibilities. This role will allow the right candidate an opportunity to work in a fun, but fast-paced environment, with experts in their field to foster continued professional development in clinical development.  

Job Responsibilities
  • Independently manage one or more clinical trials for biotech/pharma sponsor companies
  • Lead study planning activities including outline operational strategies and assumptions to develop comprehensive timelines, budgets, study management plans, and risk mitigation plans based on GCP, regulatory guidelines, and the competitive clinical landscape
  • Select and manage CROs and other vendors on behalf of clients
  • Independently manage all aspects of study management, development of study tools, training materials, recruitment plans, reports, timelines and other critical study deliverables
  • Provide ongoing updates to stakeholders via dashboards, presentations, and other appropriate communication methods
  • Proactively identify, mitigate, and raise awareness to project risks; ensure timely issue resolution
  • Support cross functional program level activities
  • Provide clinical expertise to develop written clinical strategies, documents, and relevant content for Development plans (integrated, clinical) and regulatory submissions
  • Prepare presentations and written analyses of clinical trial landscapes and development guidelines
  • Lead cross functional development team activities, including matrix team management, integration of cross functional strategies, risks, timeline, and budgets
  • Participate in internal activities such as mentoring staff, drafting articles, attending conferences when opportunities arise
  • Develop and manage client proposals and scopes of work including resource utilization and budget/scope adherence
  • Opportunity to lead and manage development team members to ensure client, employee, and company goals are achieved
  • Travel to clients’ office(s) and other locations as needed based on client and project needs
    • Up to 50% local travel for onsite and remote client support
    • Up to 15% domestic travel for client support
  • Other duties may apply
Education and Experience Requirements
  • Bachelor’s Degree in life science or similar field
  • 7-12 years of experience in a biotech or pharma setting managing clinical studies and strategic development teams
  • Development of all types of study documents, including protocols, concept sheets, and ICFs
  • Lead cross functional development teams and support writing of integrated development plans
  • Early stage clinical trial experience is preferred
  • Oncology experience is preferred
  • Medical device study and development strategy a plus
  • Must be highly proficient in MS Word, Excel, Project and PowerPoint
Characteristics of Top Performers
  • Excellent oral and written communication/presentation skills
  • Action oriented, ready for responsibility
  • Openness to learn new skills and willing to help where/when needed
  • Thorough and detail oriented
  • Forward thinking
  • Client service focused and positive attitude
  • Comfortable with ambiguity

 

Halloran Consulting Group | Senior Consultant