Senior Director, Medical Affairs Research & Operations

Description

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Executive Director, Medical Affairs Operations & Strategy, the Senior Director, Medical Affairs Research & Operations will serve as the accountable operational lead for Medical Affairs infrastructure, governance, and execution. This individual will set direction for scalable Medical Affairs capabilities across budgeting and forecasting, project and portfolio execution, performance reporting/KPI frameworks, SOP and process governance, audit readiness, sponsorships/congress oversight, ISR operations, and collaborative study management. The role will drive strategic prioritization, resource alignment, and operational recommendations that strengthen Medical Affairs execution as Viridian supports ongoing launch activities, EU expansion, and growth of the TED portfolio.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

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
• Provide leadership and oversight to 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
• Experience with investigator-sponsored research, real-world evidence/collaborative studies, or post-approval Medical Affairs research operations
• 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%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• 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
• Various fertility, mental, financial, and proactive physical health programs

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.