Nicholas Holder, MD

Experience

• 

  Western Health

  Jan 2019 - Jan 2021

  Rotations- Urology, ICU, Emergency Medicine, General Surgery Rotations- General Surgery, Emergency Medicine, General Medicine, Orthopedic Surgery

  • Hospital Medical Officer (HMO)

    Jan 2020 - Jan 2021

  • Medical Intern

    Jan 2019 - Jan 2020
• 

  Alfred Health

  Jan 2021 - Nov 2021

  Hospital Medical Officer (HMO)

  Rotations- General Medicine, Emergency Medicine, Trauma

• 

  Essendon Football Club

  Apr 2021 - Dec 2023

  VFL Team Doctor

  Head Doctor- Essendon Football Club VFL- Management of in-game medical emergencies/trauma- Longitudinal management via injury clinics

• 

  Nucleus Network

  Nov 2021 - Jun 2022

  Medical Officer

  Australia's largest Phase 1 clinical research organization- Provision of high quality clinical services to trial participants to the standards of ICH GCP.- Pharmacovigilance activities to ensure robust decision making pertaining to dose continuation, dose escalation, AE management and safety data review. - Ensure data collation/synthesis in line with regulatory requirements to ensure compliant communication material. - Collaborative engagement with cross functional departments- Pharmaceutical Sponsors, CROs, Project management, Recruitment, Resourcing, Pharmacy and QA.- Extensive experience in first-in-human, Phase 1 and Phase 2 clinical trials in various areas of pharmacology including immunologic, psychiatric, biologic, biosimilar and anti-cancer therapeutics. Show less

• 

  Therapeutic Goods Administration

  May 2022 - now

  Medical Advisor

  Medical Devices Surveillance Branch- Undertaking evaluation and assessment of clinical data provided by Sponsors to ensure Essential Principles are met for medical devices subject to Post Market Review (PMR). - Review of Device Incidence Reports (DIRs) and other safety signals to ensure safety compliance of devices listed on the Australian Register of Therapeutic Goods- ARTG.- Engage with HCPs and KOLs to ensure the continued development and revision of regulations and guidelines.- Liaison with Sponsors and other external stakeholders in the event of a product recall.- Review device advertising/ marketing/ communication material for quality, integrity and accuracy.- Execution of medical strategy to ensure compliance with regulatory guidelines. - Subject matter expert for cross-functional teams. Show less