Executive / Senior Medical Director, Early Clinical Development

Talantir; Australia; Remote; AUD 320,000 - 520,000; Full time

Job summary

Incyte is seeking a senior medical professional to lead clinical development activities in Australia for oncology and immunology/autoimmunity programs, spanning from Phase I to III. You will coordinate with Global Medical Leads, scientists, and project teams to ensure scientifically sound studies and robust regional oversight, including ethics submissions and site start-up.

This role emphasizes external partnerships, regulatory submissions, and collaboration with local and global stakeholders,

Qualifications

• MD degree with clinical development experience in oncology/IAI.
• Strong written and verbal English communication skills.

Responsibilities

• Provide medical leadership and oversight for clinical studies in Australia.
• Participate in site selection, ICF adaptation, regulatory submissions, and amendments.
• Represent medical function in site visits and coordinate with investigators and study teams.
• Collaborate with CROs, labs, and cross-functional teams to support studies.
• Monitor and summarize safety and efficacy data.
• Contribute to study design and early/late phase programs with local insights.

Skills

MD degree

Oncology/IAI experience

Leadership

Cross-functional collaboration

English communication

Education

MD in Medicine

Job description

Job Summary (Primary Function):

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. The position reports to group vice president, head of early development.

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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