Associate Director/Director of Translational Biology

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Company

Orfan

Location

San Francisco, California

Responsibilities and duties include, but not limited to:

  • Design, execute and interpret preclinical experiments in support of program delineating target therapeutic levels in First in Human and Proof of Concept studies
  • Ensure adequate consideration and implementation of all aspects of clinical pharmacology and Pharmacokinetics / Pharmacodynamics (PK/PD) for IND stage and Phase I/II program
  • Coordinate core pharmacology and toxicology studies aligned with the overall clinical development plan and regulatory submission strategy for assigned projects
  • Independently evaluate and report clinical pharmacology related results, and suggest potential modifications to project plan based on emerging data
  • Constantly look for innovative approaches in the field of pharmacology to ensure optimal utilization of resources and appropriate strategies to support program decision making in a timely and cost effective way
  • Coordinate and provide oversight of external vendors and outsource partners to ensure deliverables meet program timelines
  • Actively participate in writing Non-Clinical sections of IND, Investigator’s Brochure and PK-PD sections of Clinical Study Reports

Requirements:

  • PhD in Pharmacology or a closely related field with a minimum 7-10 years of relevant experience (4 or more within industry)
  • Prior experience in design of in vitro and animal experiments to establish PK-PD relationship of small molecule drug candidates
  • Demonstrated contributions to regulatory submissions and implementation of good documentation standards to support regulatory filings
  • Comfortable in a fast-paced environment, able to embrace change and deploy resources to provide key deliverables
  • Demonstrated leadership in a multifunctional team and the ability to collaborate with and effectively influence others
careers

Associate Director/Director of Translational Biology

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