AD, Regional Clinical Strategy & Operations

Clinical Dev

icon-location-marker Shinjuku - JP
Posted 210 days ago Full_time R1516334

Purpose/Objective of the job

This role will be the strategic and operational partner to the Head of Regional Clinical Operations Asia/Americas/Europe and specifically support the management of budget, resources, study country allocation, study execution performance, strategic efforts and communications.

Key Responsibilities and Major Duties

  • Assist functional leaders in delivering transformative operating model enhancements that improve pipeline delivery and enhance business performance
  • Assisting functional leaders in the design and implementation of short- and long-term business strategies
  • Manage resourcing model for the region and help manage workforce management plan in collaboration with CTP&OE and RDSP
  • Manages regional budget to ensure proper and efficient use of allocated budget
  • Support communication flow and plan for the region, including creating materials for regional and global meetings. Work with Country Clinical Operations Heads to plan annual Lead Country Unit Meetings
  • Assure that initiatives within the region are kept on track and managed effectively through use of formal Charter review and approval process, and oversight involvement in key global initiatives
  • Drive & coordinate regional input to the synopsis, country allocation & site identification at the country-level with CTP&OE & Country Clinical Operations Head, and be responsible for the creation of the operational execution plan across the region in collaboration with CTP&OE
  • Line management of one or more Vendor Operations Managers, assuring the application of a unified and robust Vendor management & oversight process for countries with challenging clinical outsourcing environments in the region.
  • Drive & coordinate regional review of study execution progress and overall performance metrics.
  • Work with RCO Head to implement strategies to develop people and culture in alignment with GCO and company

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility

Direct line management of Vendor Operations Manager(s)

Key Stakeholders/Contacts

Major customers are study teams across R&D including senior managers as well as external customers e.g. CROs, academic institutions, and other external suppliers.

List of minimum requirements

Bachelors or Masters  Degree within life sciences or equivalent

Experience

  • Minimum 8-10 years of relevant commercial experience in pharmaceutical or healthcare related industry required. 
  • Proven project management experience, with a strong background in the operational aspects of clinical research studies.
  • Experience in resource planning, budgeting techniques and process improvement preferred.

Competencies

  • An in-depth understanding of clinical research processes and regulations.
  • Ability to work independently in a fast moving and increasingly complex environment with limited direction is required
  • Position requires very strong written and oral communication skills, as well as strong interpersonal and organizational skills.
  • Individual must possess the ability to build alignment and drive performance across matrix teams through personal influence.
  • Demonstrates the ability to lead and motivate team members according to strategic goals.
  • Good verbal and written communication skills (both in English and local language).

Software that must be used independently and without assistance (e.g., Microsoft Suite)

  • Microsoft Suite
  • Clinical Trial Management Systems

Working Conditions

Travel Required –

  • Domestic travel to clinical trial sites
  • International travel where required