Associate Medical Director/Medical Director, Medical Safety Evaluation, Translational Medicine Immunology

Role Summary

Responsible for supporting Product Safety Leads (PSTLs) or serving as a PSTL under the supervision of the Group Medical Director to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making, and mitigate risk for developmental products and during due diligence activities.

Responsibilities

• Understand and apply pharmacology, chemistry and non-clinical toxicology to effectively conduct safety assessments
• Contribute to the authorship of key safety documents (such as the Investigator’s Brochure or Development Safety Update Report) for early development assets
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret pre-clinical and clinical safety data and communicate the analysis and interpretation to cross-functional teams
• Conduct, summarize and communicate safety assessments in due diligence activities for Immunology

Qualifications

• MD / DO with 2+ years of residency with patient management experience (required)
• Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer reviewed publication (preferred)
• Effectively analyze pre-clinical and clinical data (required)
• Background in bench or clinical research is a plus
• Effectively write technical documents with direction
• Work collaboratively in a team environment and be self-starting and able to work independently
• Ability to effectively present recommendation / opinions in a group environment
• Fluency, both written and oral, in English