Medical Director Drug Safety Job at Scienta, Cambridge, MA

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  • Scienta
  • Cambridge, MA

Job Description

Medical Director, Global Drug Safety

Seeking an experienced physician to oversee clinical safety across the full product lifecycle. This high-impact role involves cross-functional collaboration with clinical and commercial teams and requires strong medical judgment, analytical skills, and a proactive, hands-on approach to drug safety.

Key Responsibilities:

  • Lead global pharmacovigilance strategy and guide clinical teams on safety design, data analysis, and risk management.
  • Oversee signal detection, safety data review, and regulatory safety documentation (e.g., DSURs, RMPs, PSURs).
  • Serve as a safety expert in regulatory interactions and internal strategy discussions.
  • Drive safety governance and cross-functional decision-making.
  • Ensure compliance with global safety regulations and collaborate with external partners.

Qualifications:

  • MD with ≥3 years clinical practice; pharma safety leadership experience preferred.
  • Sound clinical acumen and broad therapeutic area knowledge.
  • Deep understanding of drug safety, regulatory guidelines (FDA, EMA, ICH), and clinical development.
  • Strong communication, analytical, and stakeholder management skills.
  • Proven ability to work in dynamic, fast-paced environments.

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