Job Summary (Primary Function):
Essential Functions of the Job (Key Responsibilities):
·Provide medical leadership and oversight for clinical studies in Australia, ensuring alignment with global strategy and scientific standards.
·Participate in site identification, collection and review of site documents, Informed Consent Form (ICF) adaptation, HREC submission, and regulatory applications, including support for amendments.
·Represent the medical function in site visits (including SIVs), and collaborate closely with investigators and study teams to ensure operational excellence.
·Work closely with external vendors (CROs, laboratories, etc.) and internal cross-functional teams (clinical operations, pharmacovigilance, biometrics) to support execution of global and regional studies.
·Monitor, review, and summarize clinical safety and efficacy data.
·Support the development and authorship of study protocols, clinical documents, and trial-related materials.
·Provide scientific input into study design from early development through late-stage trials, ensuring incorporation of local insights into global programs.
·Contribute to the TPOR program, including clinical protocol development and early-phase strategy.
·Build strong collaborative relationships with local and global stakeholders, including key opinion leaders and investigators.
Qualifications (Minimum Requirements):
·M.D. degree with clinical development experience in oncology and/or immunology/autoimmunity (Senior 8-years/ Executive 8+-years)
·Board certification or eligibility in oncology, hematology or an IAI-related specialty is preferred (dermatology, immunology).
·Prior experience in pharmaceutical or biotech industry is strongly preferred.
·Strong written and verbal communication skills in English.
·Demonstrated ability to work in cross-functional and multicultural teams.
·Experience engaging with clinical investigators and managing external partnerships.
·Strong leadership, organizational, and analytical skills with the ability to manage multiple priorities.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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