Senior Director, Head of Safety Operations Remote/Waltham, MA

Description

At Viridian Therapeutics, 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. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

Reporting to the Vice President, Pharmacovigilance, the Sr. Director, Head of Safety Operations is responsible for ensuring the effective management of drug safety activities. This role involves strategic leadership, operational oversight, and ensuring compliance with global regulatory and business partner requirements. The Head of Safety Operations will lead the development and implementation of safety strategies, processes, and systems to support the safety of patients and the integrity of safety data, primarily through vendors. This role will not only ensure oversight of the current PV vendors, but will develop a roadmap to enable successful global launches of the lead asset.

This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to):

• Leadership and Management: Lead and manage the safety operations team, providing direction, support, and development opportunities
• Strategic Planning: Develop and implement strategic plans for implementing and maintaining outsourced PV vendors, systems and processes aligned with company needs
• Safety Data Management: Oversee the collection, analysis, and reporting of safety data, ensuring accuracy and compliance with regulatory standards, including Med Info call center routed AE/PQC intake processes
• Regulatory Compliance: Ensure all safety operations activities comply with global regulatory requirements, including FDA, EMA, and ICH guidelines
• Process Improvement: Continuously evaluate and improve safety operations processes and systems to enhance efficiency and effectiveness
• Vendor / BP Oversight: Ensure effective oversight of PV vendor processes, performance and compliance, including compliance with business partner PVA/SDEA requirements
• SOPs and CAPA Management: Implement and maintain full suite of PV SOPs, and ensure development and implementation of PV-related CAPAs, including vendor-owned CAPAs
• Inspection Readiness: Ensure internal and PV vendor inspection readiness
• Training and Development: Provide training and mentorship to safety operations staff on pharmacovigilance practices and regulatory requirements
• Budget Management: Manage the budget for the safety operations department, ensuring efficient use of resources
• Perform other duties as assigned

Requirements

• Advanced degree in a scientific discipline (e.g., PharmD, MD, PhD) preferred with 15+ years of experience in pharmacovigilance, with at least 5 years in a leadership role
• Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments
• Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety)
• Development and review of SOPs and Work Instructions
• Vendor Management oversight responsibilities required. Experience with setting up a post-marketing PV vendor and global safety database preferred
• Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities
• Excellent verbal and written communication skills including the ability to present to both internal and external partners
• Strong analytical and problem-solving skills
• Ability to work effectively in a fast-paced, dynamic environment
• High integrity and commitment to patient safety
• Collaborative and team-oriented approach
• Approximately 10-15% travel may be required
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

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.