Job Descriptions

Job Descriptions

Explore the key roles at LinkedBio and the responsibilities each position entails.

Project Management

Clinical Project Manager

From the sponsor perspective, you lead full-lifecycle projects—from strategic clinical trial planning through execution and decision-making.

You connect development strategy with execution, going beyond day-to-day operations management.

Key Responsibilities

  • Project planning and execution leadership aligned with clinical development strategy
  • Integrated management and performance oversight of CROs, vendors, and sites
  • Integrated management of timeline, budget, scope, and quality
  • Risk identification, impact assessment, and proactive mitigation strategies
  • Decision support and alignment with internal sponsor stakeholders
  • Resolution of clinical operations issues and escalation management
  • Consistency with regulatory strategy and clinical development direction

Qualifications

  • Bachelor’s degree or higher in pharmacy, life sciences, medicine, or a related field
  • 5+ years of clinical trial project management experience
  • Experience leading Phase 1–3 trials or serving in a core role
  • CRO and vendor management experience
  • Strong understanding of clinical trial operations and GCP
  • Experience managing project timelines and budgets

Preferred

  • Experience leading global clinical trials
  • Experience across therapeutic areas (e.g., oncology, immunology)
  • English communication at a level suitable for global projects
  • Master’s degree or higher in pharmacy, life sciences, medicine, or a related field (preferred)
Regulatory Affairs

Regulatory Affairs Specialist

You strengthen interactions with regulatory authorities and approval readiness, grounded in clinical and filing strategy.

Key Responsibilities

  • IND/NDA submission strategy and submission execution
  • CTD/eCTD preparation and review; submission package management
  • Responses to MFDS and global regulatory queries
  • Alignment between clinical development strategy and regulatory requirements
  • Monitoring regulatory changes and reflecting them in strategy
  • Internal coordination among stakeholders for filing activities
  • Support for inspection readiness and regulatory response strategy

Qualifications

  • 3+ years RA experience
  • IND or NDA submission participation experience
  • Understanding of domestic and international regulatory frameworks
Business

Business Development Manager

Drive company service expansion through new client acquisition and strengthening existing client relationships. Identify sponsor needs and propose tailored solutions.

Key Responsibilities

  • New business opportunity identification and lead management
  • Proposal (RFP/RFI) writing and presentations
  • Service scope and pricing negotiation
  • Existing client relationship management and expansion opportunities
  • Market trend analysis and strategy development

Qualifications

  • 5+ years pharma/bio BD experience
  • Proposal writing and client presentation skills
  • English business communication ability