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 Dusseldorf Germany.
Provide clinical oversight for one or more projects and work with a cross functional team to plan, develop, design, implement and complete clinical development (Phase I to 3) trials. This position will have accountability for medical monitoring, analysis, and reporting of studies. These programs will involve interactions and developing strategic relationships with research and clinical experts as well as regulatory agencies. Duties may include interaction with regulatory and other partners/stakeholders in completion and submission of biologics license applications.
This position may be the project leader of one or more clinical staged projects.
Responsibilities
Provide input into the design and conduct of phase 1 to 3 clinical trials.
Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents.
Provide medical monitoring for clinical stage programs and function as the clinical representative on the cross-functional project teams.
Review individual adverse experience reports for accuracy and clinical importance and summarize their relationship to the study drug.
Answer medical safety & protocol questions directly from sites or site managers.
Lead the cross-functional study teams responsible for implementing clinical trials in support of vaccine development for early and late-stage vaccine candidates.
Partner with Regulatory Affairs and other key stakeholders on the development recommendations for clinical and regulatory strategy and represent the clinical team in regulatory interactions.
Ensures adherence to GCP/ICH standards and internal SOPs in the conduct of clinical trials.
Work with team members to prepare publications and presentations for external meetings as well as maintain responsibility for clinical sections of regulatory documents (IB, IND sections).
Responsible for the management and governance of external vendors involved in the design and clinical trials.
Interact with KOL's/Experts and participate in Advisory Boards.
Supports the company in establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Position requires travel up to 20%.
Other duties as assigned.
Remote work is acceptable.
Qualifications
MD/DO degree required with 3+ years' clinical development vaccine experience and 3+ years' relevant experience in the pharmaceutical or biotechnology industry with emphasis on vaccines. Immunology experience and/or board certification or board eligibility in Infectious Disease preferred.
Biotechnology/pharmaceutical experience in all phases of clinical trial.
Must be willing and possess the expertise to work within multi-disciplinary team of peers and outside experts.
Experience with early clinical trials, data analysis and interpretation as an understanding of safety and pharmacovigilance principles is required.
A thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines in vaccines are essential as well as knowledge of ex-US regulatory processes.
Proven success in executing clinical development studies, identify core issues and obstacles for the clinical development of a designated indication and to critically evaluate outside expert advice.
Must possess the ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies to obtain regulatory approval.
Drug safety or pharmacovigilance experience preferred.
A creative problem-solver capable of identifying risks and risk mitigation strategies.
Possesses excellent teamwork, negotiation and influencing skills, able to work in a matrix project team setting and a proven track record establishing and achieving clear and consistent goals and objectives.
Strong scientific writer and oral presenter.
For best fit, the candidate must have the ability and strong desire to "make things happen"; s/he must have a results-oriented work ethic and a positive, can-do attitude.
Highest personal values and ethical standards.
Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
