Director of Medical Affairs Operations

Job description

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity. The Director of Medical Affairs Operations will play a pivotal role in working alongside the Vice President of Medical Affairs to shape and execute the medical and product launch strategy for Rezolute’s rare disease portfolio. This role will assist in developing and implementing medical affairs strategies, working cross functionally to oversee projects in medical communications, engagement with key opinion leaders (KOLs) and other key healthcare professionals (HCPs). This role requires a balance of strategic thinking and operational execution, with an emphasis on project management and cross-functional collaboration and stakeholder communication, both internally and externally. This role will be integral to operationalizing critical components of the medical affairs department to ensure a successful product launch and sustained post-launch support. ### Key Responsibilities **1. Planning and Leadership** - Provide insights into the development and implementation of the medical affairs strategy to support the successful launch of rare disease products - Collaborate cross-functionally with clinical, commercial, and regulatory teams to ensure alignment on pre- and post-launch activities. - Partner with senior leaders to develop and execute the Medical Affairs strategy in alignment with organizational objectives. 2**. Governance and Operational Excellence:** - Drive operational efficiency by streamlining processes, workflows, and systems within Medical Affairs. - Enhance and oversee metrics and KPIs to track performance, ensuring continuous improvement. - Develop and maintain governance frameworks to support compliance, quality, and risk management. - Support the Medical Affairs system and technology roadmap to support business objectives of Medical Affairs - Support the assessment of future technologies for the department and helps direct departmental implementation of new technologies - Partner with IT to ensure project goals are in line with global business plans of action and project plans are tracked. - Partner with Finance to ensure international projects are managed with fiscal discipline and track to budget. - MSL field team effectiveness: Enhance and oversee metrics and KPIs to track performance, ensuring continuous improvement. 3**. Cross-Functional Collaboration:** - Serve as a key liaison between Medical Affairs and other functions (Commercial, Development, Manufacturing, etc.) to ensure alignment and coordination. - Facilitate effective communication and information sharing to drive seamless execution of medical strategies. - Share in oversight of the development and dissemination of scientifically accurate and compliant medical content, including publications, slide decks, and digital assets. - Ensure alignment of medical communications with the company's broader scientific and clinical objectives - Collate actionable MSL field insights to inform medical and commercial strategies. - Help guide the creation of medical education and training materials for internal and external stakeholders. **4. Program and Project Management:** - Oversee the implementation of strategic initiatives, ensuring delivery on time and within scope. - Manage cross-functional project teams to execute high-impact projects that support Medical Affairs priorities. - Create dashboards and reporting systems to track the progress of key initiatives. - Liaison with external vendors and agencies supporting medical communications and publications. - Co-develop performance metrics and provide coaching to optimize MSL impact on scientific exchange and KOL engagement. **5. Key Opinion Leader (KOL) Engagement** - Develop and maintain strong relationships with global, national, and regional KOLs in the rare disease space. - Facilitate scientific exchange and education to advance understanding of the company’s products and therapeutic areas. - Identify and collaborate with external experts for advisory boards, symposia, and scientific meetings. ### Qualifications - Minimum of 7 years of experience in medical affairs leadership within the biopharmaceutical industry, preferably in rare diseases with a minimum of a BS degree in life science, advanced degrees (MS, PhD, MBA) are preferred - Proven leadership experience in medical affairs with successful product launches, with experience in medical affairs operations including medical communication, and KOL engagement. - Strong leadership and project management experience, - Exceptional communication and interpersonal skills with the ability to influence cross-functional teams. - Deep understanding of rare disease therapeutic areas and related regulatory requirements. - Experience in designing and executing advisory boards, symposia, or investigator-initiated studies. - Familiarity with health economics and outcomes research (HEOR) to support value messaging in rare diseases. - Demonstrated ability to build strong relationships with external stakeholders.