Associate Medical Director/Medical Director, Drug Safety Physician

1 week ago

Carlsbad CA, United States Ionis Full time

Join Ionis Pharmaceuticals, Inc. in our mission to revolutionize drug discovery and transform lives for patients with unmet needs.

We are seeking a highly skilled Associate Medical Director/Medical Director, Drug Safety Physician to lead our clinical safety strategy and provide expertise in drug safety to our Clinical Development, Safety Oversight Committee, and Clinical Project Teams.

The ideal candidate will have a strong background in clinical research and a thorough knowledge of global regulatory requirements, including expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.

Key Responsibilities:

  • Develop and implement clinical safety strategies for assigned drug projects and products
  • Provide drug safety expertise and guidance to Clinical Development, Safety Oversight Committee, and Clinical Project Teams
  • Drive proactive implementation of risk management initiatives in accordance with global regulatory requirements
  • Perform individual case report assessment and determine regulatory reporting responsibilities as required
  • Provide medical review of case narratives for medical content, accuracy, and signal detection
  • Interpret aggregate safety data for periodic reports and evaluating for potential new signals

Requirements:

  • Medical degree (e.g., MD, DO)
  • At least 5 years of clinical experience post-registration
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals
  • At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery

About Ionis Pharmaceuticals, Inc.

We are a pioneer in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are committed to fostering a challenging, motivating, and rewarding environment that encourages innovation and scientific excellence.

How to Apply:

Please visit our website for more information about Ionis and to apply for this position. We are an equal opportunity employer and welcome diverse candidates to join our team.

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