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Head of Development Operations (f/m) - Germany  

Amgen (company)


Posted on : 01 May 2017

Project Description

  • The Head of Development Operations is the primary Global Study Operations (GSO) contact at the country level, leads & delivers clinical research at the country level in accordance with GCP and local regulations, oversees the quality and scientific integrity of clinical operations, and provides leadership into overall GSO activities:
  • Develops the local strategy to ensure delivery of Global Development Operations (GDO) goals in the country
  • Drives the implementation of global strategic decisions at local level
  • Responsible for efficient operation of local GSO activities – including budget, staffing and vendor management
  • Ensures quality and operational excellence in compliance with Good Clinical Practice (GCP),company standards and local regulations
  • Ensures alignment with local functions, countries and regional GSO
  • Represents GSO at the local and global level, including global leadership of initiatives/projects
  • Ensures appropriate company representation at external facing engagements

Key activities:
  • Accountable for feasibility assessments and study commitments and deliverables
  • Oversees country progress to study goals and ensure effective action plans to deliver quality and productivity deliverables
  • Manages escalated study issues, where appropriate with local Medical Director (MD), Regional Head, Clinical Program Operations Manager and/or other cross-functional partners
  • Inspection readiness activities
  • Local resource planning, operating expense and budget management
  • Staff recruitment, coaching, development, talent management and succession planning
  • Structures interactions with internal business partners and local Functional Services Provider(s) (FSPs)
  • Represents our company at external stakeholder meetings
  • Drives country strategic R&D plan jointly with local MD(s)
  • Participates in global projects as Global Study Operations representative
  • Develops local process     

  • M.D./B.Sc. (Life Sciences); Masters degree/Ph.D. preferred
  • Minimum 7 years in pharmaceutical/biotech industry
  • Clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
  • Clinical operations experience in Germany and/or regional study management experience
  • Experience at, or oversight of, outside clinical research vendors (CROs,  central labs, imaging vendors, etc.)
  • Leadership/management experience of direct reports, ideally including management level staff
  • International collaboration

  • Detailed knowledge of local country and international clinical trial management including regulations and guidelines  
  • Knowledge in company’s main therapeutic areas
  • Clinical trial processes and operations
  • Clinical project and programme management
  • GCP & other applicable regulations
  • Time, cost and quality metrics in Clinical Development as well as Finance and budgeting
  • Clinical trial cycle times

Key Competencies
  • Strong networking, relationship building and management (internal/external especially investigators
  • Analytical and problem solving skills
  • Presentation and negotiation skills
  • Excellent oral and written communication skills (German and English)
  • Ability to work under pressure, resilience, flexibility