Vera Therapeutics, Inc.

QA Engineer

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
• Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
• Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
• Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
• Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
• Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Associate Director, Clinical Quality Assurance

Compliance

• Assist the Regulatory Operations Lead in the preparation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, BLA/sBLA, MAA, CTA, NDS).
• Work with Regulatory Operations Lead, subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions, and Submissions Archive)
• Manage the preparation and submission of preclearance and Form 2253 promotional material submissions to the U.S. FDA through the Office of Prescription Drug Promotion (OPDP), ensuring completeness, accuracy, and compliance with regulatory requirements and timelines, while leveraging Veeva PromoMats to manage promotional materials and submission documentation in alignment with internal review and approval processes.
• Partner with Regulatory Affairs and MLR teams to ensure Promotional Review Committee (PRC) approved materials are finalized and submitted in accordance with FDA postmarketing promotional submission requirements.
• Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs created in a variety of formats. Maintain the internal regulatory styles template and manage submission templates.
• Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes.
• Ensure consistency across regulatory submission documents following the regulatory style guide.
• Provide technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.
• Provide input for scheduling and planning submission timelines in collaboration with Regulatory Operations Lead.
• Coordinate with external publishing vendors and consultants for on-time delivery of high quality regulatory submissions.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving regulatory submission documents/correspondence.
• Participate in the development of Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.
• Maintain knowledge of global regulatory submission requirements.
• Other duties as assigned

Senior Manager, Regulatory Operations, Publishing

Risk

• Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV.
• Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
• Provide recommendations and guidance through subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment documentation.
• Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
• Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations.
• Remain up to date and well informed on all Regulatory intelligence as it relates to risk management and relay this to the Project team and the PV medical safety science team.
• Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation Strategy (REMS).

Senior Director, Risk Management

• Proactively manage regulatory aspects of clinical studies in early to late development to create high quality regulatory submissions that support product development strategy.
• Author and review Clinical modules of applications and amendments for submission, ensuring complete regulatory content that meets current regional requirements.
• Represent Clinical Regulatory Affairs on cross-functional project teams.
• Evaluate proposed clinical protocol changes for impact to existing filings and provide strategic regulatory guidance for optimal implementation of changes.
• Establish and implement internal regulatory processes, including authoring and review SOPs and Work Instructions.
• Coordinate, track, and prioritize regulatory activities and associated resources, ensuring they are functional, consistent, and integrated to reflect cross-functional dependencies.
• Determine risk assessment and implement regulatory strategies for products in early-to-late development.
• Ensure regulatory compliance to relevant regulations.

Manager, Clinical Regulatory

Director

• Define and implement Vera's enterprise digital, social, and video communications vision, aligned with corporate brand, scientific milestones, and business priorities.
• Own and evolve Vera's enterprise digital narrative, ensuring consistency across external and internal platforms while tailoring storytelling to priority audiences.
• Serve as a strategic advisor to senior leadership on digital visibility, reputation, platform risk, and audience engagement.
• Identify, test, and responsibly pilot emerging platforms, formats, and technologies to expand reach, relevance, and trust.
• Lead integrated digital strategy across LinkedIn, X, YouTube, the corporate website, and emerging platforms, ensuring narrative cohesion, visual consistency, and performance optimization.
• Build and scale Vera's YouTube presence as a strategic storytelling, education, and thought-leadership platform.
• Develop a comprehensive video strategy across short-form, long-form, and live formats for external and internal channels.
• Establish executive-level performance frameworks and KPIs for digital, social, and video content, tied to reputation, awareness, engagement quality, and trust.

Director, Digital and Social Engagement

Marketing

• Support advisory board planning and execution through cross-functional coordination, material development, seamless execution, and synthesis and communication of key insights to broader teams.
• Oversee annual commercial advisory board plan, including compliance adherence and execution tracking.
• Support insight generation from third-party programs and communicate key learnings to inform brand strategy.
• Manage external advisory board and third-party programming vendors to ensure compliance, budget discipline, and high-quality execution of vendor activities.
• Partner with Regional Marketing Directors on conference planning, peer-to-peer journal clubs, and Commercial Steering Committee initiatives.
• Support the development and execution of the annual brand planning and tactical planning process.
• Partner with the Marketing Congress lead to support key national congresses (e.g., ASN, GlomCon, and others), with a strong focus on peer-to-peer engagement and associated initiatives.
• Serve as a cross-channel utility player, maintaining a strategic focus while flexing to support key initiatives such as congresses, speaker training, and promotional materials based on business need and individual interest.
• Maintain deep knowledge of IgA nephropathy, competitive landscape, and market dynamics to inform potential pivots in strategic and executional approach.
• Travel as needed to the home office and external meetings or conferences.

Senior Manager, Marketing Strategy

• Report to the Executive Director of Medical Information, responsible for strategy and execution of Medical Affairs training.
• Develop and scale up the Medical Affairs training curriculum and high-quality training content.
• Drive cross-functional alignment to ensure materials are accurate, consistent with core scientific messaging, and compliant.
• Partner closely with various teams to ensure launch readiness and continuous learning.

Associate Director – Medical Information and Training

• Lead hands-on execution of market access marketing initiatives in support of the launch of atacicept.
• Translate access strategy into high-quality, payer-facing marketing materials, including payer value stories, access tools, and resources to support engagement with national and regional payers.
• Lead coverage assessments and competitive access analyses to inform payer trends, access strategies, and evolving market dynamics.
• Deliver training of field-based Market Access teams and ensure readiness with access materials.
• Partner cross-functionally with National & Regional Account Directors, Trade & Distribution, Patient Hub, Marketing, Commercial Operations, HEOR, and Medical Affairs to ensure alignment, consistency, and timely delivery of access-related initiatives.
• Drive launch readiness by managing access marketing deliverables, timelines, and review processes, ensuring materials are accurate, compliant, and available to support launch milestones.
• Manage agencies and external vendors, providing clear direction and oversight to ensure high-quality, on-time execution of access marketing initiatives.
• Operate effectively in a dynamic, pre-commercial environment, adapting priorities and approaches as launch plans and organizational needs evolve.
• Contribute insights from launch execution to inform future indication expansion and lifecycle access strategies, in partnership with cross-functional stakeholders.

Associate Director, Market Access Marketing

Operations

• Collaborate with IT to manage cloud technology and reporting platforms to support analytics and reporting needs, including executive and leadership dashboards, launch and KPI reporting.
• Own and optimize CRM systems (e.g., Veeva) tailored to Vera workflows, including high valued customers, referral networks, and long sales cycles.
• Ensure accurate tracking of HCP engagement, account activity, and all other field promotional effort.
• Analyze field activity and territory performance with sensitivity to qualitative insights and traditional/non-traditional KPIs.
• Support specialty field teams (e.g., sales, regional marketing directors, field reimbursement managers and field medical) with inquiry resolution, analytics and training.
• Partner with Training and HR to support onboarding and continuous enablement for field teams.
• Design and manage highly focused territory alignments based on high valued customers, referral pathways, and regional patient density.
• Maintain targeting lists that reflect evolving diagnostic expansion, and new account discovery.
• Support incentive compensation plans designed for rare disease dynamics (e.g., milestone-based goals, team-based components).
• Administer compensation calculations and payouts with a focus on accuracy, transparency, and compliance.
• Partner with Sales Leadership to set realistic goals aligned to Vera’s goals.
• Work closely with Commercial Operations team members, Patient Services, Market Access, Medical Affairs, and Marketing to ensure aligned data, workflows, and reporting.
• Collaborate with Legal and Compliance to ensure adherence to healthcare and rare disease regulatory standards.

Associate Director, Commercial Operations

Sales

• Personally develop and deliver training assets, including slide decks, facilitator guides, learning activities, job aids, and reinforcement tools as needed
• Serve as a subject matter leader in field capability development, strengthening clinical acumen, business understanding, and customer-centric selling skills
• Ensure training consistently reflects empathy as our foundation, keeping patient impact and unmet need central to all learning
• Advance consultative, account-based, and value-driven selling behaviors appropriate for a rare disease environment
• Design scalable, repeatable learning approaches that can be sustained and adapted as the organization grows
• Use performance data, field insights, and customer feedback to diagnose capability gaps, prioritize learning needs, and refine training solutions
• Lead cross-functional collaboration with Marketing, Medical, Market Access, Legal, Regulatory, and Compliance partners to enable aligned, compliant, and timely training execution
• Act as a primary point of integration between Sales Training and key stakeholders for assigned initiatives
• Represent Sales Training perspectives in cross-functional forums, bringing clear recommendations, risk assessments, and tradeoff considerations to support aligned decision-making
• Influence without authority, demonstrating strong judgment, credibility, and relationship leadership in a highly matrixed organization
• Proactively identify and resolve alignment issues that could impact field readiness or execution
• Own execution plans, timelines, and operational readiness for assigned training initiatives
• Establish clear success metrics and evaluation approaches to assess training effectiveness and field impact
• Leverage LMS platforms and learning technologies to monitor completion, measure outcomes, and inform continuous improvement
• Synthesize insights across training metrics, field performance data, and stakeholder feedback to inform leadership discussions and strategic adjustments
• Demonstrate sound judgment in balancing urgency, quality, and compliance, making informed tradeoffs in a fast-moving biotech environment
• Oversee training logistics, communications, and vendor partnerships as needed
• When required, lead vendor selection, onboarding, and ongoing management for training partners (eLearning, content development, facilitation, technology), ensuring quality, timelines, budget adherence, and alignment with Vera’s standards and values
• Serve as a trusted thought partner to the Senior Director of Sales Training, providing insights, recommendations, and executional leadership
• Model Vera leadership behaviors through empathy, accountability, clarity, and urgency
• Contribute to a culture of continuous learning, inclusion, and high performance across the Commercial organization
• Informally coach and elevate peers and cross-functional partners through expertise, influence, and modeling of Vera leadership behaviors

Associate Director of Sales Training

Executive Assistant

• Expertly manage and prioritize the Executive Directors of Sales (and their direct-reports)) calendars, focusing on productivity, urgency, and stakeholder needs.
• Arrange comprehensive travel plans and coordinate high-profile events and meetings for Executive Directors of Sales and other sales leaders.
• Act as gatekeeper by screening and prioritizing communications and managing access to the Executive Directors of Sales and their direct-reports.
• Effectively communicate and partner with various internal and external stakeholders, ensuring smooth collaboration and coordination.
• Assist in development and organization of support materials for meetings and conferences (e.g. slide decks, presentations, meeting materials, etc.)
• Prepare and submit expense reports and manage purchase requisitions according to company policies and procedures.
• Design and implement office policies and procedures as needed.
• Analyze and monitor internal processes and suggest/implement procedural and policy changes to improve operational efficiency.
• Partner with Human Resources with various employee experience projects and programs.
• Assist with special projects and ad-hoc assignments and programs as requested.

Senior Executive Assistant

• Support Vera’s Access and Value team to inform product strategies across the company's portfolio
• Conduct business analysis to inform the Access and Value strategy, secondary data analytics, competitive intelligence, demand forecasting, and partnering with primary research
• Collaborate with Sales, Brand Marketing, Medical, Patient Services, and Finance teams to generate key insights and recommendations that influence Value and Access strategy and execution
• Proficient at insight generation, data interpretation, data reporting and analysis, and proactively communicating key insights and recommendations from an array of data inputs
• Support creating, measuring, and tracking key performance metrics for Vera products
• Develop and monitor KPIs, highlight issues, investigate and interpret data, and communicate findings to leadership to drive decisions
• Validate effectiveness of commercial strategies and tactics and provide recommendations around new performance metrics to track

Director, Managed Markets Analytics

• Informing brand strategy and engaging key external experts (KEEs) to increase advocacy.
• Supporting the educational effectiveness of KEEs through engagement and collaboration on Vera’s US Speaker Bureau.
• Building relationships with emerging thought leaders.
• Acting as the interface between HCP and market access to drive the awareness of IgAN and Atacicept.
• Organizing and moderating regional and national advisory boards.
• Collecting, analyzing, and synthesizing information on KEE sentiments and market trends.