Director/Senior Director, Project Leader
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
Reporting to the Senior Vice President of Vaccine Research, the Director / Senior Director Project Leader will drive vaccine programs and technology platforms from discovery, development, to licensure.
- Lead matrix cross-functional teams to drive one or more vaccine programs or technology platforms from discovery, development to licensure, by evaluating medical need, value proposition, and scientific / clinical feasibility, and by developing / executing a research program to address key scientific knowledge gaps.
- As part of the company’s technology search and evaluation effort, deliver new vaccine programs or technology platforms to the development pipeline, and new solutions to support life cycle of existing assets
- Lead the internal research effort of the assigned projects.
- Manage external research collaborations with corporate, academic, or non-profit institution partners, and manage relationships with partners’ project teams.
- Produce Go/No-go recommendations on the projects to governing bodies
- Support the creation and protection of intellectual property related to the led projects.
- Prepare high-quality scientific strategy and data packages to support clinical development plans and regulatory requirements for the projects.
- Represent the Company to the vaccine and academic community on the projects.
- PhD, MD, or equivalent with postdoctoral training and strong publications record
- >5 years of industry experience with deep scientific expertise in infectious diseases, vaccinology, immunology, and/or related fields
- The position requires expertise in scientific expertise in Virology and/or Microbiology
- Significant experience in preclinical R&D and discovery, with an understanding of clinical development, process development, regulatory processes, intellectual property rights, business development, and commercial strategies
- Capability to build strong relationships and collaboration, and manage stakeholder relationships, partnership programs, and technical evaluations
- Matrix leadership experience leading projects and influencing team members in the absence of direct reporting lines
- Effective communication, influencing, and presentation skills
- Proactive and innovative mindset; ability to prioritize, simplify, execute, and make decision by applying evidence and judgement to balance speed, rigor, and calculated risk
- Familiar with IP issues within vaccine development
- Able to work in a results-oriented, project-driven, real-time team environment, prioritize projects, and deliver quality results within tight time constraints
- Able to work under pressure and manage conflicting priorities
- Able to navigate and focus appropriately in a complex and rapidly changing environment
KNOWLEDGE AND SKILLS Preferred:
- Knowledge of FDA, ICH, cGMP, EU, and other regulatory guidelines
- Budgeting and forecasting, commercial, and financial acumen