Job Description

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.

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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.

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Role Overview

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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.

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Key Responsibilities

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Clinical Trial Design & Execution

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- Lead the design and execution of Phase 1 clinical trials, including Good Clinical Practice (GCP) compliance, adverse event management, and CTN submissions
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- Own development of the clinical development plan, protocol, investigator brochure or device dossier, informed consent materials, and statistical analysis strategy
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- Exercise clinical judgment on protocol-level parameters, including dosing windows, follow-up intervals, and pharmacokinetic sampling tolerances
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- Lead CRO and clinical site selection and ongoing management
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- Manage clinical trial ethics (HREC) submissions and approvals
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- Oversee clinical study reports, publication planning, and regulatory submission support
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Regulatory Support

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- Manage the outsourced regulatory consultant relationship supporting trial submissions
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- 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
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Program & Project Management

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- Own and maintain the integrated program plan and timeline across all active clinical programs, connecting formulation, device, testing, and regulatory milestones
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- Track program risks and critical decision points, and provide leadership with regular visibility into status and timelines
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- Serve as a point of contact along with the CEO for external vendors, consultants, clinical research partners, and the company's pharmaceutical partner
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- Integrate existing workstreams, including non-clinical animal studies and human tissue procurement and ethics approvals, into the unified program plan
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Selection Criteria

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- Demonstrated experience leading a Phase 1 clinical trial from protocol development through first-in-human dosing
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- Proven track record of independent clinical decision-making at the protocol level
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- Strong working knowledge of GCP, CTN/IND-equivalent regulatory submissions, and CRO/site management
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- Demonstrated experience managing complex, multi-workstream program timelines
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- Must hold current Australian work rights and be based in Melbourne
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- Experience directing or coordinating outsourced regulatory and/or quality consultants
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- Formal project management training or certification (e.g. PMP, PRINCE2), or equivalent hands-on experience
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- Familiarity with ISO 13485, ISO 14971, or QMSR quality frameworks
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- Experience with wearable or combination drug-device delivery systems
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- Experience managing multiple concurrent early-phase clinical programs
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- Prior experience in an early-stage biotechnology or medical device company
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- Strong independent decision-making and sound clinical judgment
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- Rigorous program and project management discipline across concurrent workstreams
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- High degree of ownership and accountability for outcomes
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- Ability to synthesise information across formulation, device, testing, and regulatory workstreams
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- Excellent stakeholder management and communication skills
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- Comfortable operating in a fast-paced, resource-constrained startup setting
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What We Offer

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- Direct ownership of clinical trial strategy and program execution across multiple Phase 1 programs
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- A collaborative, mission-driven team spanning formulation, device engineering, analytics, and regulatory affairs
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- The opportunity to shape clinical operations practices for a growing MedTech company
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- A clear growth pathway as the program advances through clinical development
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- Equity participation in a growing MedTech company
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Remagine Labs is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all team members.

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📌 Clinical Operations & Program Lead (Victoria)
🏢 @
📍 Victoria