Overview
Associate Medical Director Location: Sydney or Melbourne, Australia. The Associate Medical Director provides strategic medical, clinical, and scientific leadership across IQVIA projects. This role partners closely with project teams, clients, and investigative sites to ensure high quality medical oversight throughout the clinical trial lifecycle, while also contributing expert input to business development and scientific strategy. The Associate Medical Director serves as a Global Medical Advisor on assigned studies, delivering medical expertise across protocol development, study conduct, safety oversight, and reporting. The role plays a critical part in ensuring patient safety, scientific integrity, and regulatory compliance, while acting as a trusted medical interface with sponsors and investigators.
Responsibilities
* Primarily serves as Global Medical Advisor for assigned clinical trials, with an emphasis on early phase oncology and/or hematology studies (Phase I–II).
* Acts as Scientific Advisor to Project Leaders, providing medical and scientific guidance throughout study delivery.
* Provides medical support to investigative sites and internal teams for protocol related issues, including: Eligibility and inclusion/exclusion criteria determinations; Patient safety assessments; Protocol clarifications and deviations.
* Performs medical review of key study documents, including: Protocols; Investigator's Brochure (IB) / Investigational Drug Dossier; Case Report Forms (CRFs).
* Reviews and provides medical clarification of trial related Adverse Events (AEs).
* Performs medical case review of Serious Adverse Events (SAEs), including review of narratives and source documentation, in collaboration with Pharmacovigilance.
* Supports Analysis of Similar Events (AOSE) activities as required.
* May provide medical review of adverse event coding and safety trends.
* Provides therapeutic area and protocol training to clinical project teams.
* Attends and presents at Investigator Meetings, client meetings, kick off meetings, and regular project team meetings.
* Performs medical review of Clinical Study Reports (CSRs) and patient narratives.
* Acts as a medical expert supporting business development activities, including: Proposal input; Medical feasibility assessments; Client discussions and bid defences.
* Builds and maintains strong working relationships with sponsors, investigators, and internal stakeholders.
* Responds to urgent, protocol related medical queries from investigative sites, in line with local Labor Laws.
* Willingness to travel domestically and internationally, as required.
* Extensive use of computers and telecommunication tools to support distributed study teams.
Qualifications & Experience
* Medical degree (MD or equivalent) from an accredited and internationally recognized medical school.
* Specialist training and clinical experience as an Oncologist and/or Haematologist is preferred.
* Current or prior medical license to practice medicine.
* Board certification or equivalent specialist recognition in oncology or hematology strongly preferred.
* Typically 5–7+ years of post graduate clinical experience; prior industry or clinical research experience highly desirable.
* Demonstrated experience in early phase oncology/hematology clinical trials (Phase I and/or first in human studies strongly preferred).
* Experience in medical monitoring, protocol review, and safety oversight within a CRO, biopharmaceutical, or academic research setting is advantageous.
* Strong, current knowledge of: Oncology and/or hematology therapeutic landscapes; Clinical trial methodology and drug development; Relevant global and local regulatory requirements (GCP, ICH, TGA, FDA, EMA).
* High level of scientific and clinical judgment, with a patient centric mindset.
* Strong communication, presentation, and stakeholder engagement skills.
* Demonstrated business acumen and ability to contribute to strategic discussions.
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