Executive / Senior Medical Director, Early Clinical Development

Executive / Senior Medical Director, Early Clinical Development

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Overview : This position is responsible for implementing clinical drug development activities for Incyte’s oncology and immunology / autoimmunity (IAI) pipeline from Phase I through Phase III in Australia, ensuring that studies conducted are scientifically and medically sound.

The role works closely with Global Medical Leads, Clinical Research Scientists, and the broader Global Project Team. The position also provides regional research and development oversight, including responsibilities related to site selection, ethics and regulatory submissions, and study start-up.

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)

We are an equal opportunities employer and welcome applications from all qualified candidates.

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