Associate Director, Medical Affairs Operations

Rezolute•Redwood City, CA

About The Position

The Associate Director, Medical Affairs Operations supports the implementation, coordination, and ongoing management of Medical Affairs operational capabilities, processes, systems, and infrastructure. The role translates established Medical Affairs priorities into operational plans, processes, and deliverables for pre-launch, launch, post-launch, and future pipeline activities. Reporting to the Executive Director, Medical Affairs Strategy & Operations, the position supports operational capabilities, infrastructure, governance, and launch readiness in alignment with functional leadership priorities, resource allocation, and key operational decisions. The successful candidate will combine project management skills, operational expertise, initiative, and attention to detail with the ability to manage assigned responsibilities independently and collaborate across functions. The role contributes to building scalable Medical Affairs infrastructure and processes as Rezolute evolves into a commercial-stage organization. The position also supports Medical Affairs programs, systems and technology, compliance and governance processes, budget and vendor management, operational metrics, and cross-functional execution.

Requirements

Bachelor's degree in life sciences, healthcare, business administration, or a related discipline required.
Minimum of 5–7 years of relevant experience within the biopharmaceutical industry, including 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 Field Medical, Medical Communications, Medical Information, Medical Education, congress activities, and external scientific engagements.
Working knowledge of Medical Affairs governance, SOPs, MLR processes, and applicable regulatory and compliance requirements.
Ability to manage multiple projects independently, establish execution priorities within approved direction, identify dependencies and risks, and drive deliverables to 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.
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.
High degree of accountability, adaptability, initiative, integrity, and commitment to operational excellence and compliance.

Nice To Haves

Advanced degree.
Experience implementing, administering, or optimizing Medical Affairs technology platforms, including Veeva CRM, Veeva Vault/PromoMats, or comparable systems.
Experience in rare diseases, specialty therapeutics, launch preparation, or growing biotechnology organizations.

Responsibilities

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 Medical Affairs activities and facilitate planning meetings; document decisions and action items and drive follow-through.
Develop and maintain project trackers, operational dashboards, milestone reports, and risk and dependency logs; identify execution risks and recommend solutions or escalate significant issues.
Coordinate implementation, administration, and optimization of Medical Affairs systems and technologies, including platforms such as Veeva CRM and Veeva Vault/PromoMats.
Partner with Information Technology, Compliance, functional stakeholders, and vendors on system configuration, integration, testing, deployment, and ongoing support.
Maintain system workflows, documentation, user guidance, and training resources; coordinate onboarding, access, troubleshooting, and process enhancements.
Coordinate drafting, implementation, maintenance, and review of Medical Affairs SOPs, policies, and operational processes.
Support governance processes for MLR review, HCP interactions, advisory boards, medical education, grants, congress activities, and other Medical Affairs programs.
Maintain operational documentation, templates, tracking tools, and records to support compliance and inspection readiness; collaborate on process assessments, audits, and corrective or preventive actions.
Provide operational and project management support for Field Medical, Medical Communications, Medical Information, Medical Education, congress activities, advisory boards, and external scientific engagements.
Coordinate timelines, logistics, vendors, documentation, and deliverables for assigned initiatives; support Medical Affairs launch readiness plans and track launch milestones, dependencies, and risks.
Support budget development, forecasting, and resource planning; manage assigned expense tracking, purchase orders, invoices, contracting workflows, and budget reconciliation.
Coordinate vendor identification, onboarding, contracting, and ongoing management; monitor vendor deliverables, timelines, performance, expenditures, and records of agreements and commitments.
Develop and maintain operational dashboards, reporting tools, and performance tracking mechanisms; collect, consolidate, and report operational data and prepare updates for Medical Affairs leadership.
Monitor execution against approved plans, identify trends and opportunities, and recommend or implement approved improvements to operational processes and infrastructure.
Collaborate with Medical Affairs and cross-functional teams to facilitate operational alignment, information sharing, resolution of dependencies, and follow-through on leadership decisions.
Represent Medical Affairs Operations in assigned project teams, working groups, and operational meetings, communicating progress, challenges, and recommendations.
Perform other duties as assigned.