Dynavax Technologies

Operations

• Lead the translation and implementation of marketing strategies to support HEPLISAV-B® in the retail segment.
• Support the brand strategy and promotional efforts for the retail segment for HEPLISAV-B® and develop personal and non-personal resources and materials to drive adoption and expansion in this key segment.
• Collaborate with the Retail Sales Team to ensure alignment with strategic objectives, training on core materials, messaging, and pull-through.
• Measure, monitor, evaluate and report on the effectiveness of marketing programs in the retail segment to inform investment decisions.
• Develop and manage annual conference planning for retail and work cross functionally with all attendees including the preparation of all related promotional materials and presentations.
• Effectively work with multiple agency partners to develop core marketing materials. Serve as project lead to ensure deliverables are met within approved timelines and budget.
• Partner with promotional review board members to ensure efficient MRB (Material Review Board) team operation and compliant promotional tactics.
• Oversee marketing operations and MRB management, ensuring timely and effective project management of all initiatives.

Senior Director, Retail Marketing – Operations

Compliance

• Provide regulatory oversight for multiple projects focused on non-clinical and clinical aspects of drug development and associated regulations.
• Collaborate within Regulatory as well as with functional counterparts to ensure a global regulatory strategy is created and executed for all assigned projects.
• Align with senior leadership on each proposed project regulatory strategy.
• Serve as the internal Regulatory leader for other region activities (e.g., EU/UK filings, global partnerships, ex-US clinical trial applications).
• Support all regulatory activities across the company’s overall regulatory strategy, spanning preclinical to Phase 4 product development, including marketed product activities.
• Develop and implement regulatory strategies for assigned products based on regulations, guidance, precedents, and regulatory landscape.
• Develop relationships with FDA contacts and lead FDA engagement strategies and execution.
• Guide submissions to the INDs and BLA, tracking commitments and submission requirements.
• Partner with cross-functional subject matter experts to develop a CCDS / country label prior to Phase 3 to support the path to registration.
• Drive development of (s)BLA strategy for registration of assigned programs.
• Coordinate submission requirements and regulatory engagement strategies in collaboration with external resources.

Senior Director, Regulatory Affairs

Director

• Lead clinical supplies function, including direct reports if applicable, in the overall strategy and execution relating to management, packaging and labeling, forecasting, delivery, storage and accountability of investigational medicinal product (IMP) for Dynavax clinical trials and Investigator Initiated Research.
• Lead interactions with Regulatory, Quality Assurance (QA), and Clinical in the design and approval of labels for primary and secondary packaging to meet country-specific labeling requirements, including translation of required label text into appropriate languages.
• Ensure the clinical supplies operations meets GCP and GMP standards and internal benchmarks for quality and compliance. Lead or participate in initiatives to improve quality in any area related to clinical supplies.
• Provide Clinical with packaging options that best meet the needs of the clinical trial design.
• Update pharmacy manuals and other documentation and/or manuals as needed.
• Lead discussions with Clinical to determine the best supply strategy for efficient use of IMP and standard of care (SOC) medication. Balance project and corporate goals with expiry dates and study timing to ensure adequate, but not excessive, overages are employed in the supply strategy.
• In consultation with internal stakeholders, identify, evaluate, and select suitable vendors, both domestic and international, for packaging, labeling, and storage of IMP.
• Manage internal contracting process for onboarding selected vendors including but not limited to completion of purchase requests and contract review and execution.
• Contribute to the development of the operating plan by projecting clinical supply costs and long-range planning estimates. Responsible for generating and managing clinical supply cost estimates for each clinical study, including budget forecasting, accruals, re-projections, and scenario-based planning to support strategic decision-making and financial oversight.
• Effectively negotiate contracts with vendors and manage vendor adherence to contracts.
• Manage execution of packaging and labeling to ensure activities are performed according to cGMP, including technical review of master and executed batch records.
• Manage shipment of active pharmaceutical ingredients (APIs), drug substance, adjuvant, comparator product, and/or study-related devices to ensure timely delivery of materials to the appropriate drug product contract manufacturing organization and subsequent transfer of the drug product to the packaging and labeling vendor.
• Manage the clinical inventory of all manufactured materials, including API, drug substance, adjuvant, intermediate, and drug product.
• Effectively partner across functional lines to ensure timely release and shipment of IMP, placebo, diluent, and SOC to clinical sites.
• Manage product inventory through coordination with Clinical Operations to ensure adequate IMP, placebo, diluent, and SOC supply is available at the clinical sites for the duration of the clinical trial.
• In consultation with Clinical Operations, manage the final reconciliation of IMP at the close of each clinical trial.
• Ensure clinical supply documentation is submitted to the eTMF as appropriate. Participate in functional QC reviews of eTMF documentation as needed.
• Manage temperature-sensitive shipments and notify applicable stakeholders about issues and potential solutions in a timely manner.
• Monitor temperature excursion interactions to ensure appropriate reporting, management and disposition of materials, arranging for resupply, if necessary.
• Stay abreast of current US and international regulatory guidance on packaging and labeling requirements; interface with Regulatory for projects as needed.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Work with cross-functional teams on long-range planning for clinical development programs.
• Other duties as assigned.

Director, Clinical Supplies

Research Analyst

• Help to execute assigned clinical studies and ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives
• Daily activities may vary depending on the clinical phase of the program and may support more than one study
• Collaborate with contract research organization (CRO) personnel and study sites to ensure studies are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, SOPs and overall clinical objectives
• Manage study deliverables, including clinical study start-up activities, clinical supply logistics, enrollment, data collection, and close-out in consultation with study leads
• Participate in on-site and remote monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits
• Review monitoring visit reports and track resolution of action items
• Actively participate in the preparation of study-related clinical documents
• Support the selection of sites and CROs and planning of clinical meetings as needed
• Assist with the review of clinical trial data and listings
• Assist with filing of clinical documents in the TMF, as applicable

Clinical Research Associate II – Contractor

AI Engineer

• Central accountability to implement responsible Data and AI practices that comply with evolving regulations (e.g. GDPR; EU AI Act or Industry standards) and Dynavax ethical principles
• Lead efforts to streamline data processes, improve data quality and consistency, and enable more efficient analytical capabilities across the organization
• Build an AI-ready data foundation that allows leveraging machine learning and artificial intelligence to enhance business decision-making across all domains
• Advise the Dynavax Data and AI committee on AI solutions, investments and benefit analysis (e.g. ROI)
• Work collaboratively across the business and IT and demonstrate excellent communication and stakeholder management skills
• Help improve data and AI literacy across the organization
• Design and implement a robust data ecosystem that supports business-wide processes and digital transformation
• Play a key role in the strategic cloud migration initiative to transform enterprise data architecture into a modern, cloud-native ecosystem

Senior Director, Data and AI Architecture

Account Executive

• Full account responsibility and business ownership for assigned Retail Pharmacy Account(s) to establish and grow HEPLISAV-B sales.
• Establish effective working relationships with designated leaders across designated retail banners.
• Complete vertical ownership of assigned field-based Division/Region/District leaders for designated retail pharmacy banner(s).
• Work directly with the National Account Directors to provide pull through support for National initiatives within designated Retail Pharmacy Banners.
• Responsible for achieving sales targets and owning/managing relationships for assigned Accounts/Call Targets, including top-to-bottom vertical ownership of HQ and field-based retail leaders and associated sites.
• Understand market dynamics and customer business models to identify opportunities and develop strategies and tactics across assigned accounts/call targets.
• Develop relationships with key stakeholders who influence National/Region/District decision making.
• Ensure effective top down and bottom up account management to influence positive purchasing outcomes for HEPLISAV-B across assigned accounts/call targets.
• Execute all functions of the role independently with minimal supervision from Director, Vaccine Sales and/or assigned mentor for executive level customer engagements.
• Partner with Director, Vaccine Sales and National Account Director(s) to execute sales and marketing strategies to support increased adult Hep B vaccination and HEPLISAV-B adoption within assigned accounts/call targets.
• Provide quarterly business updates and performance assessment to leadership and develop and communicate effective account plans while monitoring progress.
• Collaborate with Marketing team to understand strategic direction, tactics, and partnership opportunities for assigned Retail HQ customers.
• Exercise sound judgment and oversight to ensure integrity and compliance with company policies in all activities and communications.
• Foster Dynavax Vision, Core Values and Strong Culture to Win as a team and Grow as an individual.
• Maintain accurate up-to-date customer records in the Account Management system.
• Field based role requiring approximately 60% travel.
• Other duties as assigned.

Senior Director, Retail Marketing – Operations

Senior Director, Regulatory Affairs

Director, Clinical Supplies

Clinical Research Associate II – Contractor

Senior Director, Data and AI Architecture

Retail Key Account Executive II