about 2 hours ago

Senior Director, Clinical Development Scientist

Vancouver, WA

$262,000-$315,000 / year

full-timedirectorbiotechnology

Description

In this pivotal role, you will help translate Absci's AI-powered drug design into successful drug development programs, spanning clinical science deliverables for development programs and individual trials. You will leverage deep expertise in clinical trial design/execution, medical data oversight, and scientific communication to generate high-quality data and build the scientific foundation for advancing pipeline assets.

Requirements

  • PhD or PharmD required
  • 10+ years of pharmaceutical or biotechnology clinical drug development experience
  • Demonstrated track record in late-phase (Phase 2/3) trial execution, scientific data review, and data quality oversight
  • Proven ability to bridge clinical development and medical affairs functions
  • Experience with KOL management and publication strategy
  • Experience contributing to regulatory submissions and authoring clinical regulatory documents
  • Strong written and oral communication skills

Responsibilities

  • Develop expertise in assigned therapeutic areas to serve as clinical and scientific subject-matter expert
  • Engage clinical investigators and study sites to ensure timely and quality study execution
  • Ideate study designs, protocols, charters, publication plans and deliverables
  • Support investigators, site staff, CROs/CRAs on study protocol and related questions
  • Work closely with medical monitors on proactive data review and safety signal identification
  • Collaborate cross-functionally to drive protocol development and governance approval
  • Partner to translate clinical strategy into study concept documents and regulatory materials
  • Build and maintain relationships with external key opinion leaders
  • Manage relationships with external stakeholders including KOLs, advocacy groups, and foundations
  • Maintain company awareness of scientific, clinical and competitive landscape
  • Contribute to medical affairs activities including scientific communication and KOL strategy
  • Contribute to regulatory submissions and health authority interactions
  • Present scientific findings internally and externally; serve as author on publications
  • Provide guidance on management of CROs, collaborators, and consultants
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