Senior Vice President Clinical Development - Ophthalmology

Shanghai Permanent
  • Overall responsibility for Clinical functions supporting Ocular disease pipeline
  • Innovative drugs for unmet medical needs in China

About Our Client

Our client is China headquarters Biotech company supported by global investment funds. Following in-licensing model, they are concentrating their efforts around under-served indications for ophthalmology and chronic disease management.

Job Description

  • Lead the Clinical Development team across planning, design, development, and implementation of clinical trials for all product candidates across all phases
  • Interface with KOLs to create clinical development strategies for various products
  • Provide pharmacovigilance oversight and manage timely reporting of safety signals to regulatory agencies
  • Guide Research and development/discovery team on decisions that have clinical components and implications
  • Maintain accountability for all relevant time-lines and deliverables working closely with functional counterparts and colleagues integration of product and clinical development plans
  • Manage the writing of protocols, presentations, and publications (regulatory submissions, original peer-reviewed articles, abstracts)
  • Review key documents including protocols, investigator brochures, and informed consent forms, etc.
  • Work closely with Clinical Operations to select between outsourcing and in-house approaches for Clinical Development activities
  • Maintain the quality clinical programs, following GCP and ICH guidelines
  • Help guide overall company strategy and trajectory
  • Provide leadership and mentor ship to team members
  • Contribute to creating an open and collaborative working environment driven by common goals and competitive time-lines.

The Successful Applicant

  • MD or MD/PhD with 10+ years of industry experience; experience in a small to mid-sized biotech company is preferred
  • Ophthalmology clinical backgrounds preferred
  • Proven track record of drug development with Phase I through III trial experience preferred
  • Outstanding communication and leadership skills accompanied by a readiness to "roll up the sleeves" to contribute to team efforts
  • Excellent writing skills with a track record of publications and polished presentation skills to influence internal and external audiences
  • Ability to develop creative approaches to processes, practices, services, business models, and strategy
  • Takes personal accountability for outcomes and thrives on increasing levels of responsibility to move the business forward
  • Regulatory experience with Pre-INDs, INDs and NDA/BLAs
  • Experience having managed significant accelerations and challenges in clinical programs

What's on Offer

We are looking for a passionate and energetic Clinical Development professional keen to join a fast growing and innovative team.

Maria Karp
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Job summary

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Maria Karp
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