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Job Details

Location
Shanghai
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-19251
Contact
Richard Hao
Contact email
Email Richard
Posted
about 1 month ago
Shanghai, China
Industry: Pharmacy, Biotech
 

We are a clinical-stage biotech organization in China, driven by our commitment to science and patient needs. Our mission is to discover, develop, and commercialize innovative, safe, affordable medicines, with a focus on endocrine, cardiovascular, and metabolic diseases, and women's health. We leverage internal R&D capabilities, external technology, and in-licensing to address unmet medical needs and build a patient-focused portfolio.
 

Job Description Summary:
 
General Description:

  • Make strategic planning and lead execution of clinical operations’ deliverables at the site management team in the region, or country level, or defined level.
  • Lead therapeutic areas within Clinical Operations with responsibility for line management, strategic planning, and alignment with broader organizational goals.
  • Provide expert knowledge on the execution of clinical trials, expert understanding of ICH/GCP Guidelines and other applicable regulatory requirements.
  • Establish company’s reputation and capability for successful delivery of clinical trials, in partnership with CROs as applicable
  • Build up site management team at the regional level, and develop direct and indirect reports to ensure greater value added to the business across all areas
  • Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations function to drive faster, high quality clinical trials
 

Qualification Required:

Essential Functions of the job:

  • Contribute to and take accountability for overall Clinical Operations strategy and performance.
  • Provide leadership to Clinical Operations Department including managing and executing on clinical trials, and ensures cost, quality and timeline align with plans.
  • Contributes to and has accountability for overall site management team strategy and performance against key metrics.
  • Lead team to set up and/or develop region-level partnerships with key sites to engage investigators to facilitate clinical trial execution.
  • Identify clinical program and resource gaps, risk and potential issues. Coordinate the risk management and issue resolution process and seek improvement.
  • Escalate issues to Company Senior Management team timely.
  • Manage and ensure team has appropriate qualifications.
  • Monitor team compliance with SOP and training curriculum, applicable ICH/GCP and applicable regulations.
  • Ensure alignment with broader company strategic initiatives and business needs. Identify opportunities and initiatives within the broader organization that can be adopted and implemented by Clinical Operations as best practice. Takes initiative for issue resolution within and outside the Clinical Operations department.
  • Contribute to vendor selection process and sourcing strategy development.
  • Communicate with internal and external staff effectively with a professional and collaborative approach.
  • Ensure Clinical Operations thinking, and activities are aligned with overall business direction and priorities.
  • Champion a global mindset and approach across Clinical Operations to strength collaboration and consistency across Company.
  • Ensure that multiple, novel ideas on how to deliver on clinical trials are generated and considered.

Supervisory Responsibilities

  • Manage team in accordance with organization’s policies and applicable regulations.
  • Direct internal staffing and performance management including hiring, training, coaching, and performance reviews.
  • Drive team members to improve their efficiency and effectiveness at prioritizing work and improving performance.
  • Ensure prioritization of activities and resourcing is in line with clinical development programs.
  • Drives for operational excellence.
  • Foster a collaborative highly integrated culture.
  • Maintain a positive, results orientated, collaborative highly integrated culture.
 
Other Qualifications:
  
  • Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
  • More than 10 years in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field.
  • Minimum of 8 years of project management and/or clinical operation experience
  • Excellent interpersonal skills, strong organizational skills, and effective written and verbal communication skills. Evidence of team leadership capabilities.
  • Fluent in spoken and written English as you will liaise with English and Chinese speaking stakeholders.

Travel: 

  • Travel will be required for business purpose.
 

Competencies:

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity



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