Director Clinical Operations
2 weeks ago
Job Title: Director of Clinical Operations
Location:
Australia (Sydney strongly preferred)
Job Type:
Starting part-time, moving to full through end of year
About Us:
Xylo Bio is developing targeted neurotherapeutics to transform the lives of patients with neurological and psychiatric conditions. By combining advanced neuroscience with computational drug discovery, Xylo is evolving a category-defining GPCR platform to produce neuroplastogens capable of rewiring neural circuits and restoring brain function.
Position Summary:
We are seeking a highly experienced and hands-on Director of Clinical Operations to lead the planning and execution of our global clinical trials from Phase I (first-in-human) through regulatory submission. The ideal candidate will have experience managing both Australian and international neuropsychiatric trials, with a track record of success in early- to late-phase programs.
Key Responsibilities:
- Lead clinical operations strategy and execution across multiple programs from FIH through to clinical approval.
- Oversee clinical trial planning, protocol development, site feasibility, CRO/vendor selection and management, and study execution.
- Ensure trials are conducted according to ICH GCP, and in accordance with regional regulatory requirements (TGA, FDA, etc.)
- Responsible for ensuring operational excellence in our clinical stage programs by applying highest industry standards, policies, systems and processes across all trials.
- Collaborate cross-functionally with regulatory, translational, clinical science, and CMC teams to align timelines and deliverables.
- Manage budgets, timelines, and resource allocation across one or more studies.
- Develop and implement resource management and trial metric tracking tools, and establish performance goals by role. Develop and maintain systems for effectively managing service provider relationships.
- Establish trial infrastructure in Australia and contribute to international expansion efforts.
- Serve as the primary clinical operations point of contact with investigators, CROs, and regulatory authorities.
- Build and lead a nimble clinical operations team as the company scales.
Qualifications:
- Bachelor's degree and 10+ years of experience in clinical trial operations, with direct leadership responsibility for FIH through Phase III studies.
- Background in neuroscience or psychiatry trials (CNS, mood disorders, pain, or similar indications) strongly preferred.
- Experience running trials both in Australia and globally, ideally including the US or EU.
- Demonstrated ability to manage CROs, vendors, and investigator relationships with a hands-on and pragmatic approach.
- In-depth understanding of regulatory and ethical approval processes in Australia (HREC/TGA) and internationally.
- Prior experience in a biotech or fast-paced startup environment strongly preferred.
- Excellent organizational and communication skills.
- Life sciences degree required; advanced degree (e.g. MSc, MPH, PhD) is a plus.
- Previous experience contributing to IND or NDA/MAA submissions.
- Willingness to travel within Australia and internationally.
- Must be curious, humble, and a team player.
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