Remagine Labs is a pioneering MedTech company developing a wearable drug delivery platform for chronic conditions, in strategic partnership with a global pharmaceutical company.
We are driven by innovation and the ambition to improve the lives of patients worldwide.
Remagine Labs is seeking an experienced Clinical Operations & Program Lead to direct clinical trial execution and own the integrated program plan across multiple parallel Phase 1 programs.
This is a senior, hands-on delivery role with direct accountability for trial execution and program timelines.
Role Overview
The Clinical Operations & Program Lead will run trial execution end-to-end across the company's parallel Phase 1 programs, and own the integrated program plan connecting formulation, device, testing, and regulatory workstreams.
This is a delivery role: the Lead is expected to run trial operations and the program schedule directly, not oversee others running them.
Key Responsibilities
Clinical Trial Design & Execution
Lead the design and execution of Phase 1 clinical trials, including Good Clinical Practice (GCP) compliance, adverse event management, and CTN submissions
Own development of the clinical development plan, protocol, investigator brochure or device dossier, informed consent materials, and statistical analysis strategy
Exercise clinical judgment on protocol-level parameters, including dosing windows, follow-up intervals, and pharmacokinetic sampling tolerances
Lead CRO and clinical site selection and ongoing management
Manage clinical trial ethics (HREC) submissions and approvals
Oversee clinical study reports, publication planning, and regulatory submission support
Regulatory Support




Manage the outsourced regulatory consultant relationship supporting trial submissions
Determine the non-clinical and device testing required to support the trial and regulatory submission (e.g. biocompatibility, device safety, stability), consistent with device classification and materials, and schedule testing activities against trial timelines
Program & Project Management
Own and maintain the integrated program plan and timeline across all active clinical programs, connecting formulation, device, testing, and regulatory milestones
Track program risks and critical decision points, and provide leadership with regular visibility into status and timelines
Serve as a point of contact along with the CEO for external vendors, consultants, clinical research partners, and the company's pharmaceutical partner
Integrate existing workstreams, including non-clinical animal studies and human tissue procurement and ethics approvals, into the unified program plan
Selection Criteria
Demonstrated experience leading a Phase 1 clinical trial from protocol development through first-in-human dosing
Proven track record of independent clinical decision-making at the protocol level
Strong working knowledge of GCP, CTN/IND-equivalent regulatory submissions, and CRO/site management
Demonstrated experience managing complex,



multi-workstream program timelines
Must hold current Australian work rights and be based in Melbourne
Experience directing or coordinating outsourced regulatory and/or quality consultants
Formal project management training or certification (e.g. PMP, PRINCE2), or equivalent hands-on experience
Familiarity with ISO *****, ISO *****, or QMSR quality frameworks
Experience with wearable or combination drug-device delivery systems
Experience managing multiple concurrent early-phase clinical programs
Prior experience in an early-stage biotechnology or medical device company
Strong independent decision-making and sound clinical judgment
Rigorous program and project management discipline across concurrent workstreams
High degree of ownership and accountability for outcomes
Ability to synthesise information across formulation, device, testing, and regulatory workstreams
Excellent stakeholder management and communication skills
Comfortable operating in a fast-paced, resource-constrained startup environment
What We Offer
Direct ownership of clinical trial strategy and program execution across multiple Phase 1 programs
A collaborative, mission-driven team spanning formulation, device engineering, analytics, and regulatory affairs
The opportunity to shape clinical operations practices for a growing MedTech company
A clear growth pathway as the program advances through clinical development
Equity participation in a growing MedTech company
Remagine Labs is an equal prospect employer.
We celebrate diversity and are committed to creating an inclusive environment for all team members.
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📌 Clinical Operations & Program Lead (Melbourne)
🏢 @
📍 Melbourne