Clinical Operations & Program Lead

About Us

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

Essential

• 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

Desirable

• 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 13485, ISO 14971, 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

Key Competencies

• 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 opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all team members.

To apply, click “Quick Apply” with your curriculum vitae and a short cover letter addressing the selection criteria, including a Phase 1 clinical trial you have taken from protocol development through to first dose and your specific role in it.