Senior Director, Medical Affairs Research & Operations

Responsibilities

• Medical Affairs Operations, Governance & Process Excellence
• Establish, scale, and continuously improve Medical Affairs operational infrastructure, including cross-functional governance processes, operating models, and fit-for-purpose ways of working
• Lead and direct SOP development, management, and Medical Affairs process governance, ensuring processes are clear, compliant, scalable, and aligned with Medical, Legal, Compliance, Finance, Regulatory, Clinical Development, and other key partners
• Drive alignment across with Medical Affairs leadership to support annual and long-range Medical Affairs planning, prioritization, and operational execution across major functional workstreams
• Budget Ownership, Forecasting & Performance Tracking
• Serve as the accountable operational lead for Medical Affairs budget oversight processes, including forecasting, spend tracking, variance monitoring, and coordination with Finance and functional budget owners
• Set the strategy and governance for and operationalize Medical Affairs performance reporting, Medical Affairs dashboards, KPI tracking, and achievement reporting to support leadership visibility and data-driven decision-making
• Ensure budget and performance reporting processes are reliable, repeatable, and audit-ready across U.S. and ex-U.S. Medical Affairs activities
• Project Management, Sponsorships & Congress Oversight
• Provide oversight of Medical Affairs project management across priority initiatives, ensuring clear owners, timelines, milestones, risks, and decision points
• Oversee operational planning for sponsorships and congresses, partnering with internal stakeholders and vendors to ensure compliant and timely execution
• Drive excellence in project management and execution across Medical Affairs initiatives, including launch-related and post-launch activities
• ISR, Research Operations & Collaborative Studies
• Oversee ISR operational infrastructure, including intake, committee processes, documentation, budget coordination, tracking, and reporting
• Partner with Medical Affairs, Clinical Development, Legal, Compliance, Finance, Pharmacovigilance, Regulatory, and external investigators to support compliant review and execution of investigator-sponsored and collaborative research
• Oversee the ISR committee process and support management of collaborative studies, including operational tracking, governance, and study progress reporting
• Audit Readiness, Compliance & Risk Management
• Own Medical Affairs audit-readiness planning for operational processes, including documentation, controls, decision records, and governance artifacts
• Drive alignment with Compliance, Legal, Quality, and other relevant functions to support inspection readiness and continuous improvement of Medical Affairs processes
• Identify operational risks, assess trade-offs, and recommend mitigation plans for high-priority Medical Affairs workstreams
• Cross-Functional operational and Team Leadership
• Provide operational leadership for US/ex-US Medical Affairs partnerships and Medical Affairs model operationalization as Viridian expands its footprint outside the United States
• Serve as a senior operational partner to Medical Affairs, Field Medical, Scientific Communications/Publications, Medical Communications, International, Finance, Legal, Compliance, and other cross-functional teams
• Lead and oversee Medical Affairs Operations executional resources, including coordination with the Operations Manager and external vendors/partners as needed

Qualifications

• Bachelor’s degree required; advanced degree (PharmD, PhD, MD, MS, MPH, MBA, or equivalent) highly preferred
• Requires 15+ years of experience in the pharmaceutical/biotechnology industry, with substantial experience in Medical Affairs operations, medical strategy, program management, research operations, or related functions
• Demonstrated experience leading Medical Affairs operations, budget oversight, dashboarding/KPI tracking, SOP/process governance, and cross-functional project execution
• Strong understanding of healthcare compliance, medical review governance, audit readiness, documentation practices, and cross-functional decision-making in a regulated environment
• Experience supporting product launch, post-launch execution, or global/ex-US Medical Affairs expansion strongly preferred
• Demonstrated ability to manage vendors, influence without authority, and coordinate senior stakeholders across Medical, Finance, Legal, Compliance, Regulatory, Clinical Development, Field Medical, and external partners
• Excellent project/program management skills with the ability to translate strategy into operational plans, dashboards, timelines, and measurable outcomes
• Strong analytical, communication, and executive presentation skills; ability to synthesize complex operational information into clear leadership updates
• Comfort with ambiguity and agility to operate in a fast-paced, launch-stage organization
• Strong commitment to ethical standards and compliant Medical Affairs operations
• Ability to travel up to 25-40%

Benefits

• Competitive pay and stock options for all employees
• Competitive medical, dental, and vision insurance
• 100% Paid Parental Leave
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Variety of fertility, mental, financial, and proactive physical health programs