Medical Monitor IV

Medical Monitor (Contract)

Responsibilities

• Provide clinical development support across late-stage programs, including scientific review, interpretation of clinical data, and preparation of regulatory deliverables.
• Collaborate with Clinical Development, Biometrics, Regulatory Affairs, Pharmacovigilance, and CRO partners to support clinical trial execution and reporting.
• Review and interpret clinical trial data, including tables, listings, and figures (TLFs).
• Support medical data review, data cleaning, and issue resolution with internal teams and CROs.
• Analyze safety and efficacy data, including post hoc and exploratory analyses.
• Author, review, and finalize key clinical and regulatory documents, including:
  • Clinical Study Reports (CSRs)
  • Integrated Summary of Safety (ISS)
  • Integrated Summary of Efficacy (ISE)
  • Investigator’s Brochure (IB) updates
  • Development Safety Update Reports (DSURs)
  • Clinical sections of regulatory submissions and briefing documents
  • Study narratives and narrative reviews
• Contribute to the development and review of:
  • Clinical protocols and protocol amendments
  • Informed Consent Forms (ICFs)
  • Statistical Analysis Plans (SAPs) in collaboration with Biometrics
  • Clinical trial plans and supporting study documentation
• Provide clinical guidance on protocol interpretation and study conduct during trial execution.
• Serve as the clinical point of contact for CROs and external vendors.
• Participate in CRO meetings to address protocol questions, data review issues, and trial conduct topics.
• Review CRO deliverables related to clinical data, reports, and regulatory submissions.
• Participate in Safety Review Team meetings and collaborate with Pharmacovigilance on safety assessments.
• Review emerging safety signals and contribute to benefit-risk evaluations and safety documentation.
• Support cross-program documentation, regulatory responses, and inspection readiness activities as needed.

Qualifications

• MD or DO required.
• Minimum of 5 years of drug development experience within the pharmaceutical or biotechnology industry.
• Experience serving as a Medical Monitor or supporting clinical development programs.
• Experience reviewing clinical trial safety and efficacy data.
• Experience authoring and reviewing clinical and regulatory documents, including CSRs, ISS/ISE, IBs, DSURs, and clinical protocols.
• Experience collaborating with cross-functional teams, including Biometrics, Regulatory Affairs, Pharmacovigilance, and CRO partners.
• Experience supporting late-stage clinical development programs preferred.
• Nephrology and/or Immunology therapeutic area experience preferred.
• Strong clinical data interpretation, scientific writing, and communication skills.
• Ability to manage multiple priorities in a collaborative, cross-functional environment.