Join a trailblazing biotech driving breakthrough treatments in oncology. We are seeking an experienced and hands-on Medical Director to join a dynamic, science-driven team leading the charge in immuno-oncology.
Our Client's lead T-cell engager is first-in-class, demonstrating impressive survival data in solid tumours. Following success in recent Phase I/II studies the company is progressing to a Phase IIb randomised controlled trial based in Melbourne, Australia.
Why Join?
- Ground-breaking Science : Product is first-in-class with unprecedented survival data in the 3rd/4th-line colorectal cancer setting. Opportunity to lead a first-in-class clinical program with high unmet need
- Clinical Momentum : Strong ASCO presentation feedback, robust interest from investigators, and clear differentiation in a space with few competitors.
- High-Impact Role : Lead the clinical strategy in a pivotal trial, with support from a seasoned CMO and a high-performing biotech team.
- Agile, Mission-Driven Culture : Flat structure, collaborative ethos, flexible working arrangement and a genuine passion to improve patient outcomes
This is a unique opportunity for a driven and capable Medical Director with strong experience in clinical development to contribute strategically and operationally across a dynamic oncology pipeline. You’ll play a vital role in protocol development, regulatory submissions, site engagement, and safety oversight.
Key Responsibilities
Reporting to the CMO, and working closely with internal teams and external partners (CROs, sites, KOLs), you will:
- Provide medical oversight for clinical trials for the upcoming Australia-based Phase IIb study.
- Lead or support the development of clinical study documents, including synopses, protocols, ICFs, investigator brochures, and clinical sections of regulatory submissions (e.g. pre-IND/IND).
- Engage directly with clinical sites and investigators, answering protocol questions and supporting patient enrolment and eligibility assessment.
- Partner with pharmacovigilance providers to assess safety events, determine reportability, review MedWatch reports, and prepare DSURs.
- Collaborate with Clinical Operations to ensure optimal study set-up and delivery.
- Support regulatory strategy with interface across R&D, CMC, and external stakeholders.
- Lead the medical review of data, identify trends and contribute to medical strategy.
- Prepare and present data to internal stakeholders, safety monitoring committees, and at scientific conferences.
- Draft manuscripts for peer-reviewed journals to disseminate key clinical findings.
- Medical degree
- Significant experience in clinical development in either biotech, pharma, or a CRO setting.
- Oncology experience preferred but not essential. Open to other therapeutic areas if industry exposure is robust
- Experience in protocol authorship and regulatory submissions.
- Strong knowledge of clinical trial processes, GCP, and global regulatory requirements.
- Exceptional communication and presentation skills.
- Demonstrated ability to work cross-functionally and manage external partners.
- Based in Australia, Victoria.
If you're driven by science, inspired by impact, and thrive in high-growth biotech environments, we’d love to hear from you.
�55357;�56553; Apply now or reach out confidentially to learn more about this exciting opportunity.
