Associate Director, Medical Affairs Operations

About this role

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tumor HI).

The Associate Director, Medical Affairs Operations will play a key role in supporting the implementation, coordination, and ongoing management of Medical Affairs operational capabilities, processes, systems, and infrastructure to enable effective execution of Medical Affairs strategies and initiatives.

Reporting to the Executive Director, Medical Affairs Strategy & Operations, this individual will translate established Medical Affairs priorities into operational plans, processes, and deliverables supporting pre-launch, launch, post-launch, and future pipeline activities. The position will support the Executive Director in advancing Medical Affairs operational capabilities, infrastructure, governance, and launch readiness, while maintaining alignment with functional leadership on priorities, resource allocation, and key operational decisions.

The successful candidate will combine strong project management skills, operational expertise, initiative, and attention to detail with the ability to independently manage assigned responsibilities and collaborate effectively across functions. This individual will contribute to building scalable Medical Affairs infrastructure and operational processes appropriate for Rezolute's evolution into a commercial-stage organization.

Key Responsibilities

1. Medical Affairs Operational Planning & Execution

• Translate established Medical Affairs strategies and priorities into operational project plans, timelines, milestones, deliverables, and tracking mechanisms.

• Manage assigned Medical Affairs operational initiatives and projects from planning through execution, ensuring alignment with approved objectives and timelines.

• Coordinate activities across Medical Affairs functions to support effective implementation of approved initiatives and launch readiness priorities.

• Develop and maintain integrated project trackers, operational dashboards, milestone reports, and risk and dependency logs.

• Facilitate operational planning meetings, document decisions and action items, and drive follow-through on assigned responsibilities.

• Identify operational challenges, resource constraints, and execution risks; recommend solutions and escalate significant issues to Medical Affairs leadership as appropriate.

2. Medical Affairs Systems, Technology & Infrastructure

• Coordinate implementation, administration, and ongoing optimization of Medical Affairs systems and technologies based on functional requirements, priorities, and governance established by Medical Affairs leadership.

• Support implementation and management of platforms such as Veeva CRM, Veeva Vault/PromoMats, and other relevant Medical Affairs technology solutions.

• Partner with Information Technology, Compliance, functional stakeholders, and external vendors to coordinate system configuration, integration, testing, deployment, and ongoing support.

• Develop and maintain standardized workflows, system documentation, user guidance, and training resources.

• Coordinate system onboarding, user access, troubleshooting, and process enhancements to support effective adoption and utilization.

• Identify and recommend opportunities to improve operational efficiency, data management, reporting, and knowledge sharing through technology.

3. Medical Affairs Governance, Compliance & Process Management

• Coordinate drafting, implementation, maintenance, and periodic review of Medical Affairs standard operating procedures (SOPs), policies, and operational processes under the direction and oversight of Medical Affairs leadership and appropriate functional stakeholders.

• Support implementation and administration of governance processes for Medical-Legal-Regulatory (MLR) review, HCP interactions, advisory boards, medical education, grants, congress activities, and other Medical Affairs programs.

• Develop and maintain operational documentation, templates, tracking tools, and records to support compliance, consistency, and inspection readiness.

• Collaborate with Legal, Regulatory, Compliance, and other functions to ensure operational processes are aligned with applicable requirements and approved company policies.

• Support periodic process assessments, internal audits, and corrective or preventive actions as appropriate.

• Identify opportunities to simplify and standardize workflows and implement approved process improvements.

4. Medical Affairs Programs & Launch Readiness

• Provide operational and project management support for Medical Affairs programs, including Field Medical, Medical Communications, Medical Information, Medical Education, congress activities, advisory boards, and external scientific engagements.

• Coordinate timelines, logistics, vendors, documentation, and deliverables associated with assigned Medical Affairs initiatives.

• Support implementation of Medical Affairs launch readiness plans, including operational infrastructure, systems, processes, training coordination, and functional preparedness.

• Track progress against established launch milestones, identify dependencies and risks, and communicate updates to Medical Affairs leadership.

• Partner with Medical Affairs functional leads to facilitate timely, consistent, and compliant execution of approved programs.

• Coordinate with cross-functional stakeholders as appropriate to support operational alignment and execution.

5. Budget, Resource & Vendor Management

• Support Medical Affairs leadership in budget development, forecasting, and resource planning through preparation of financial data, tracking reports, and operational…