Associate Director, Medical Affairs Operations

Job description

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 analyses. - Manage assigned activities related to expense tracking, purchase orders, invoices, contracting workflows, and budget reconciliation. - Coordinate vendor identification, onboarding, contracting, and ongoing management in accordance with approved procurement processes and Medical Affairs leadership direction. - Monitor vendor deliverables, project timelines, performance, and expenditures against approved budgets and contractual expectations. - Maintain accurate records of vendor agreements, financial commitments, and operational expenditures. - Identify opportunities to improve vendor coordination, resource utilization, and operational cost efficiency. **6. Operational Metrics, Reporting & Continuous Improvement** - Develop and maintain operational dashboards, reporting tools, and performance tracking mechanisms aligned with Medical Affairs leadership-defined objectives and key performance indicators (KPIs). - Coordinate collection, consolidation, and reporting of operational data across Medical Affairs systems, programs, and functional teams. - Prepare periodic operational performance reports, project updates, and launch readiness summaries for Medical Affairs leadership. - Monitor execution against approved operational plans and identify trends, challenges, and opportunities for improvement. - Recommend and implement approved process improvements to enhance operational efficiency, consistency, scalability, and accountability. - Support ongoing evaluation and refinement of Medical Affairs operational processes and infrastructure as organizational needs evolve. **7. Cross-Functional Collaboration & Operational Coordination** - Collaborate with Medical Affairs, Clinical Development, Commercial Operations, Regulatory, Legal, Compliance, Finance, Information Technology, Patient Affairs, and other relevant functions to facilitate coordinated operational execution. - Support implementation of cross-functional workflows and processes that enable effective collaboration while maintaining appropriate Medical Affairs functional independence and compliance requirements. - Facilitate communication, information sharing, and resolution of operational dependencies across internal and external stakeholders. - Represent Medical Affairs Operations in assigned project teams, working groups, and operational meetings, communicating progress, challenges, and recommendations to Medical Affairs leadership. - Support implementation of leadership decisions and ensure appropriate operational follow-through across affected stakeholders. **8. Other Responsibilities** - Perform other duties as assigned. ### Qualifications & Expected Capabilities - Bachelor's degree in life sciences, healthcare, business administration, or a related discipline required; advanced degree preferred. - Minimum of 5–7 years of relevant experience within the biopharmaceutical industry, including experience in Medical Affairs operations, project management, or related functions. - Demonstrated experience supporting Medical Affairs operational activities, systems, infrastructure, and processes within a pharmaceutical or biotechnology organization. - Familiarity with core Medical Affairs capabilities, including Field Medical, Medical Communications, Medical Information, Medical Education, congress activities, and external scientific engagements. - Experience implementing, administering, or optimizing Medical Affairs technology platforms, including Veeva CRM, Veeva Vault/PromoMats, or comparable systems preferred. - Working knowledge of Medical Affairs governance, SOPs, MLR processes, and applicable regulatory and compliance requirements. - Demonstrated ability to manage multiple projects independently, establish executional priorities within approved direction, identify dependencies and risks, and drive deliverables through completion. - Experience coordinating vendors, contracts, budgets, purchase orders, and financial tracking processes. - Strong proficiency with Microsoft Office applications, project management tools, and operational reporting systems. - Demonstrated ability to collaborate effectively with cross-functional stakeholders and external partners in a matrixed environment. - Strong organizational, analytical, problem-solving, and communication skills, with exceptional attention to detail. - Ability to balance independent execution with appropriate communication, escalation, and alignment with functional leadership. - Experience in rare diseases, specialty therapeutics, launch preparation, or growing biotechnology organizations preferred. - High degree of accountability, adaptability, initiative, integrity, and commitment to operational excellence and compliance.