Associate Director, Medical Affairs Operations

Rezolute•Redwood City, CA

6d•$195,000 - $225,000

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 supporting pre-launch, launch, post-launch, and future pipeline activities. Reporting to the Executive Director, Medical Affairs Strategy & Operations, this individual advances operational capabilities, infrastructure, governance, and launch readiness in alignment with functional leadership priorities and resource decisions. The role requires project management and operational expertise, initiative, attention to detail, independent execution, and effective cross-functional collaboration to help build scalable Medical Affairs operations as Rezolute develops into a commercial-stage organization. The position manages operational initiatives and project plans; coordinates Medical Affairs systems and technology; supports governance, compliance processes, and documentation; and provides program, launch-readiness, budget, vendor, and reporting support. It also works across internal functions and external partners to coordinate execution, track progress and risks, and implement approved process improvements. The stated base salary range is $195,000 to $225,000, depending in part on location and qualifications. The role is eligible for an annual performance bonus and includes stock options and a comprehensive benefits package.

Requirements

Bachelor's degree in life sciences, healthcare, business administration, or a related discipline.
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 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 independently manage multiple projects, set 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 Medical Affairs strategies and priorities into operational plans, timelines, milestones, deliverables, and tracking mechanisms.
Manage assigned Medical Affairs operational initiatives and projects from planning through execution, coordinating activities and monitoring alignment with objectives and timelines.
Maintain project trackers, dashboards, milestone reports, and risk and dependency logs; facilitate planning meetings and document decisions and action items.
Identify operational challenges, resource constraints, and execution risks; recommend solutions and escalate significant issues to Medical Affairs leadership as appropriate.
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, stakeholders, and vendors on system configuration, integration, testing, deployment, and ongoing support.
Maintain workflows, system documentation, user guidance, and training resources; coordinate onboarding, user access, troubleshooting, and process enhancements.
Coordinate drafting, implementation, maintenance, and periodic 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 for compliance, consistency, and inspection readiness; support process assessments, audits, and corrective or preventive actions.
Provide project management and operational 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 Medical Affairs initiatives and support implementation of launch-readiness plans.
Track launch milestones, dependencies, and risks, and communicate updates to Medical Affairs leadership.
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 deliverables, timelines, performance, and expenditures, and maintain related records.
Develop operational dashboards and reporting tools; collect, consolidate, and report operational data and prepare performance reports, project updates, and launch-readiness summaries.
Monitor execution against operational plans, identify trends and improvement opportunities, and recommend and implement approved process improvements.
Collaborate with Medical Affairs and cross-functional partners to coordinate workflows, communication, information sharing, and resolution of operational dependencies.
Represent Medical Affairs Operations in assigned project teams, working groups, and meetings; communicate progress, challenges, and recommendations and support follow-through on leadership decisions.
Perform other duties as assigned.