DBV Technologies

Quality Specialist

• Support the Quality Systems team within a pharmaceutical/biotech environment for a 6-12 month contract
• Manage controlled documentation and training processes, ensuring compliance with GxP standards
• Support audit readiness activities
• Process controlled documents (SOPs, Work Instructions, forms) through the Veeva Vault QualityDocs workflow
• Manage document metadata and ensure accuracy and completeness
• Route documents for review and approval in accordance with established procedures
• Execute periodic document reviews under the guidance of senior QA staff
• Assign and track training within ComplianceWire
• Monitor training completion and follow up on overdue assignments
• Troubleshoot user/learner issues and provide system support
• Maintain records in accordance with GxP retention requirements

Quality Document Specialist

Director

• Act as a subject matter expert on the health outcomes and economic impact of the VIASKIN Peanut Patch and the broader peanut allergy treatment landscape.
• Engage with national and regional payers, pharmacy benefit managers, integrated delivery networks, employers, and population health key opinion leaders to provide scientific, clinical, and economic information about VIASKIN Peanut.
• Communicate the value proposition of epicutaneous immunotherapy, including efficacy, safety, patch wear-time, and real-world relevance, to support informed coverage and formulary decisions.
• Conduct educational programs, scientific presentations, and value-evidence discussions to enhance understanding of product outcomes data among payer and population health audiences.
• Establish and maintain strong relationships with key external stakeholders, including medical and pharmacy directors, payer decision-makers, professional societies, and patient advocacy organizations in the food allergy community.
• Disseminate health outcomes data, real-world evidence, health economic models, and budget-impact analyses to support informed decision-making by payers and population health customers.
• Collaborate with internal cross-functional teams—including Market Access, Medical Affairs, Value & Access, Commercial, and Field Reimbursement—to align evidence strategies and ensure consistent, accurate messaging ahead of and through launch.
• Past history of designing outcomes based analytics using internal data sources or from external vendors. (e.g. Patient services data, Medical affairs, IQVIA, Optum Insights, Komodo)
• Provide training to internal teams on outcomes data and value evidence, ensuring a consistent and accurate understanding across the organization.
• Address unsolicited inquiries from payers and population health decision-makers regarding product information, clinical data, and outcomes research, in accordance with applicable regulations and company policy.
• Support investigator-initiated studies, real-world evidence generation, and other research initiatives that contribute to the understanding of health outcomes in pediatric peanut allergy.
• Contribute to the development of strategic plans for health outcomes research, value-evidence communication, and payer engagement in support of the VIASKIN Peanut launch.
• Collaborate with internal stakeholders to integrate health outcomes strategies into broader product launch, access, and commercialization plans.
• Ensure that all communication and interactions comply with regulatory requirements, legal guidance, and company policies.

National Outcomes Director – Payer

• Act as a subject matter expert on the health outcomes and economic impact of the VIASKIN Peanut Patch and the broader peanut allergy treatment landscape.
• Engage with national and regional payers, pharmacy benefit managers, integrated delivery networks, employers, and population health key opinion leaders to provide scientific, clinical, and economic information about VIASKIN Peanut.
• Communicate the value proposition of epicutaneous immunotherapy, including efficacy, safety, patch wear-time, and real-world relevance, to support informed coverage and formulary decisions.
• Conduct educational programs, scientific presentations, and value-evidence discussions to enhance understanding of product outcomes data among payer and population health audiences.
• Establish and maintain strong relationships with key external stakeholders, including medical and pharmacy directors, payer decision-makers, professional societies, and patient advocacy organizations in the food allergy community.
• Disseminate health outcomes data, real-world evidence, health economic models, and budget-impact analyses to support informed decision-making by payers and population health customers.
• Collaborate with internal cross-functional teams—including Market Access, Medical Affairs, Value & Access, Commercial, and Field Reimbursement—to align evidence strategies and ensure consistent, accurate messaging ahead of and through launch.
• Provide training to internal teams on outcomes data and value evidence, ensuring a consistent and accurate understanding across the organization.
• Address unsolicited inquiries from payers and population health decision-makers regarding product information, clinical data, and outcomes research, in accordance with applicable regulations and company policy.
• Support investigator-initiated studies, real-world evidence generation, and other research initiatives that contribute to the understanding of health outcomes in pediatric peanut allergy.
• Contribute to the development of strategic plans for health outcomes research, value-evidence communication, and payer engagement in support of the VIASKIN Peanut launch.
• Collaborate with internal stakeholders to integrate health outcomes strategies into broader product launch, access, and commercialization plans.
• Ensure that all communication and interactions comply with regulatory requirements, legal guidance, and company policies.

National Outcomes Director – VIASKIN® Peanut

• Serve as lead for DBV relationship and B2B engagement with assigned accounts
• Identify competitive threats and develop response strategies to ensure optimal access for products
• Develop and own account-level plans for assigned national or regional payers, inclusive of formulary strategy, coverage policy objectives, and contracting priorities
• Establish and maintain executive-level relationships with medical directors, pharmacy directors, and formulary committee decision-makers
• Lead payer negotiations and contracting discussions in partnership with the Market Access contracting team, ensuring alignment with overall pricing strategy
• Communicate the clinical, economic, and humanistic value of Viaskin® Peanut to payer audiences, translating HEOR data and real-world evidence into decision-relevant insights
• Effectively articulate the differentiated profile of EPIT as a novel, non-invasive immunotherapy in a competitive and evolving food allergy treatment landscape
• Develop and deliver tailored account-specific value dossiers and budget impact models in collaboration with HEOR and medical affairs
• Anticipate and proactively address payer policy questions and potential coverage barriers prior to launch
• Partner with patient services and hub operations to ensure reimbursement pathways are operationally aligned with payer coverage decisions
• Contribute to the development of payer-facing materials and market access tools in partnership with marketing and regulatory
• Establish KPIs to monitor progress and area of opportunity
• Works closely with Regional Account Manager(s) and sales leadership to drive field force communications on relevant reimbursement issues and pull through maximization
• Serve as the voice of the payer internally, providing competitive intelligence, formulary landscape updates, and account-specific feedback to inform brand strategy
• Partner closely with field outcomes teams to ensure coordinated account engagement
• Represent market access in account-level business reviews and brand team planning cycles

Director, Corporate National Accounts – West Coast

• Develop and execute a comprehensive area business plan aligned to national commercial strategy, encompassing territory prioritization, resource allocation, KOL engagement, and quarterly milestone tracking.
• Deliver area net sales, market share, and patient start targets by leading, directing, and enabling a team of Regional Business Directors and their Regional Account Managers
• Analyze area performance data and field intelligence to identify trends, opportunities, and risks; adjust tactics proactively to maximize commercial impact.
• Serve as a senior commercial architect during pre-launch and launch phases; lead area-level market shaping, KOL development, and disease state awareness initiatives.
• Identify area-specific market access barriers, competitive dynamics, and adoption challenges; escalate actionable insights to the VP, Sales and commercial operations
• Develop deep expertise in peanut allergy epidemiology, EPIT mechanism of action, clinical trial data (EPITOPE, VITESSE), and the competitive landscape to shape strategy and coach the field team.
• Partner closely with Medical Science Liaisons (MSLs), Market Access Corporate Account Directors, Marketing, and Patient Services to deliver an integrated, customer-centric approach across the area.
• Achieve or exceed quarterly and annual area sales objectives while operating within all compliance and regulatory requirements.

Executive Business Director

• Lead the HCP personal promotions strategy in preparation for the launch of Viaskin® Peanut, inclusive of end-to-end development, PRC submission, and lifecycle management of the full personal HCP promotional toolkit: visual aids, detail aids, leave-behinds, reprint carriers, rep-triggered and approved emails, clinical training materials, and objection-handling guides.
• Oversee field materials supply chain: print production, inventory management, fulfillment vendor relationships, distribution logistics, and material obsolescence/recall processes.
• Lead strategy and execution for all non-personal promotion (NPP) channels targeting HCPs: digital display, programmatic, journal ads, direct mail, headquarter emails, and sponsored programming.
• Develop and manage the annual HCP media plan: channel mix, audience targeting, budget allocation, and flight scheduling.
• Own web content strategy and day-to-day management of HCP-facing digital properties: branded professional website, microsites, and gated portals.
• Develop and maintain HCP journey maps; design omni-channel contact strategies sequencing personal promotion, NPP, digital, and P2P channels into a coherent prescriber experience.
• Partner with Commercial Operations and Commercial Data Strategy to implement trigger-based content sequences and next-best-action logic in CRM and marketing automation.
• Develop HCP promotional content for National and Regional POA meetings; collaborate with Sales Training on TBM promotional material certification.
• Manage day-to-day relationships with HCP advertising agency of record, digital agency, and media agency; oversee SOW, project timelines, budgets, and deliverable quality.

Director, HCP Promotions

QA Engineer

• Manage all quality aspects overseeing and maintaining compliance of U.S. distribution operations with applicable regulatory requirements, Quality Technical Agreement, Good Distribution Practices (GDP) and DBV Quality Policy & relevant SOPs.
• Ensure the application of regulatory compliance principles in accordance with FDA compliance trends.
• Supervise and develop team member(s), providing leadership to support ongoing operational excellence.
• Perform 3PL, warehouse, transportation providers oversight.
• Ensure compliance with the quality policy for distribution third parties and DBV's AQ operations activities.
• Oversee and approve quality-related activities including change controls, deviations, CAPAs, and investigations related to distribution operations.
• Escalate any issues per the DBV escalation policy and initiate any market action that is required.
• Maintain quality oversight of temperature control, including monitoring, excursions management, and stability considerations.
• Monitor the ERP interface with 3PL and DBV team.
• Lead the Quality Risk assessments.
• Assess the performance of the contractor(s) annually.
• Implement and maintain Standard Operating Procedures defining all the processes for managing of contactor(s).