Head of APAC Clinical Operations - pre-IPO biotech - Oncology

Shanghai Permanent
  • Global clinical trials for BIC Oncology Assets
  • Global leadership team

About Our Client

Our client is pre-IPO global clinical-stage research-based biotechnology company focused on discovering, developing and commercialising cut-edge biologic therapies. They primary focus in on Oncology and Autoimmune disease. Their mission is to develop innovative biologic therapies for patients globally by pushing boundaries of basic science.

Job Description

  • Design and deliver high quality clinical trials and study reports while navigating global requirements and managing external vendors
  • Lead and develop Clinical Operations team to improve daily processes and assure long-term excellence
  • CRO oversight, compliance to SOPs, protocols, management plans and budget
  • Closely partner with Clinical Development department and other stakeholders by contributing to Clinical Development plans
  • Develop and drive strategy of Phase I to III clinical trials for multiple oncology indications
  • Oversee clinical project schedules, time-lines, budgets, and key performance milestones to meet corporate objectives
  • Closely monitor and comply with ICH, CFDA, MHLW, FDA and EMA requirements for SOPs

The Successful Applicant

  • Advanced degree in Medical or similar field and at least 8+ years of experience in the industry with a multinational clinical operations environment
  • Experience in clinical pharmacology, data management, pharmacovigilance, medical science will be a plus
  • Excellent knowledge of CFDA, MHLW, TGA, FDA and EMA regulations and expectations, GCPs, ICH guidelines for all phases of Clinical Development
  • Solid knowledge of biologic drugs for Oncology field will be preferred
  • Successful track record of direct contribution to global drug development and approvals for China market and beyond
  • Ability to lead under pressure and navigate through complex environments

What's on Offer

You will be offered competitive salary package and bonus scheme along with the opportunity to learn from a global team of professionals.

Maria Karp
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Maria Karp
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