Vera Therapeutics, Inc.

Medical Director

• Facilitate scientific training for the field medical team focused on disease state
• Assist medical information in preparing the team for scientific milestones
• Initiate scientific practice sessions including mock dialogues
• Support scientific-readiness learning following major publications
• Lead new-hire scientific onboarding with targeted scientific exercises
• Partner with field medical leadership to provide individualized coaching
• Strengthen team capability in identifying, interpreting, and communicating competitive intelligence
• Communicate observed CI trends and insight themes to medical leadership
• Maintain an assigned geographic territory and execute all core responsibilities of an FMD
• Engage with KEEs through meetings as well as at congresses and advisory boards
• Deliver proactive disease state education and discussions regarding product data
• Partner with Medical Communications, Publications, Clinical Development, HEOR, and Compliance
• Participate in special projects as necessary
• Travel required (up to 50%)

Field Medical Director, Trainer

• Engage with Key External Experts through meetings (both face-to-face and virtual) as well as at congresses and advisory boards.
• Expected to deliver proactive disease state education, and reactive discussions regarding product and clinical trial data.
• Provide appropriate scientific, clinical, and educational support to internal and external customers.
• Build a territory plan and establish key relationships with external communities, including professional societies.
• Support cross-functional medical pre-launch processes to ensure launch readiness and medical excellence.
• Take an active role in the planning and execution of educational activities at key scientific congresses and help develop the medical affairs congress strategy at both the national and regional levels, in collaboration with the medical affairs team.
• Lead and/or participate in special projects as necessary.
• Travel required (up to 50%).

Field Medical Director

Manager

• Own and manage the lifecycle of reference standards and critical reagents, including primary, working, interim, in-house, compendial, and assay control/standards from receipt and qualification through issuance, requalification, and retirement.
• Review and assess analytical data associated with reference standard qualification, stability monitoring, trending, and assay performance.
• Author, review, and approve GMP documentation including SOPs, qualification/requalification protocols and reports, CoAs/CoCs, deviations, CAPAs, change controls, and technical reports.
• Establish and maintain strategies for qualification, characterization, bridging, and requalification of reference standards and critical reagents to support analytical testing and product release.
• Ensure uninterrupted supply, inventory control, storage, labeling, distribution, and tracking of qualified reference standards and critical reagents for GMP operations.
• Define and oversee appropriate storage, handling, shipping, and environmental monitoring requirements, including management of temperature excursions and investigations.
• Collaborate with Analytical Development, QC, and external laboratories to support method qualification, validation, comparability assessments, and commercial specification setting activities.
• Maintain accurate and inspection-ready records within electronic systems.
• Support investigations related to deviations, OOS/OOT results, atypical trends, and risk assessments associated with reference standards and critical reagents.
• Partner with Regulatory Affairs to support regulatory filings, responses to health authority questions, and preparation of analytical sections related to reference standards and assay controls.
• Support internal audits, external inspections, and health authority inspections by ensuring inspection readiness of documentation and systems.
• Manage activities at CDMOs and contract testing laboratories related to reference standard qualification, inventory management, and analytical support.
• Drive continuous improvement initiatives to enhance operational efficiency, compliance, scalability, and business continuity for reference standard and reagent management processes.

Senior Manager, Reference Standards – Reagents

Vice President

• Lead global clinical safety, pharmacovigilance and risk management activities throughout the product lifecycle for investigational and marketed products across the pipeline
• Build and manage a high-performing, inspection-ready pharmacovigilance team by setting clear expectations & providing hands-on leadership, promoting operational excellence, collaboration and team cohesiveness
• Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, public presentations and key scientific articles and abstracts
• Ensure robust processes are in place for case processing, aggregate reporting, signal detection, benefit–risk assessment, and risk management
• Advise Leadership on safety matters and provide strategies for addressing benefit-risk and risk management, including communication to patients, health care providers, and regulatory authorities
• Partner with Regulatory Affairs, Clinical Development, and Quality Assurance to ensure full compliance with GVP, GCP, and corporate quality standards
• Provide medical guidance and evaluation of all pre- and post-marketing safety data
• Collaborate cross-functionally and with key internal and external stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Senior management, regulatory agencies, alliance partners, investigators and key external experts

Vice President, Pharmacovigilance

Operations

• Leads the manufacturing and supply chain teams, providing leadership aligned with Vera values resulting in a high performing organization.
• Contributes to the strategic leadership of Vera’s late-stage programs acting as a strong team player.
• Participate in sales and operations planning (S&OP) and Product Development Teams representing the Product Development and Manufacturing function.
• Create synergy and knowledge sharing to enable optimal production planning processes to balance supply/demand risks.
• Serves as a single point of contact to manage end-to-end global supply chain and foster the needed supplier relationships to drive excellence using appropriate metrics.
• Serves as a strategic thought leader to craft and manage commercial supply contracts with an eye towards life cycle extension programs.
• Create, develop and manage necessary tools for end-to-end demand/supply planning.
• Provide strategic direction, technical guidance, and long-range planning for late-stage programs: BLA-enabling studies through BLA submission, commercial launch, and sustaining operations.
• Develop and manage department budgets and ensure fiscal responsibility for manufacturing operations.
• Develop fit for purpose operational processes and systems to support supplier metrics and other tools to enable continuous improvement / process excellence.

Vice President, Commercial Manufacturing Operations

Director

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Field Medical Director, Trainer

Field Medical Director

Senior Manager, Reference Standards – Reagents

Vice President, Pharmacovigilance

Vice President, Commercial Manufacturing Operations

Associate Director, GxP Systems