Vice President, Clinical Development
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. This position is responsible for establishing the clinical development strategy for the company’s product pipeline. The incumbent’s responsibilities will include, but not be limited to, oversee the design and execution of clinical trials – Phase 1 to Phase 3; lead and manage the Clinical development team in support of regulatory submissions to successfully advance clinical pipeline to regulatory approval. The incumbent in this position may represent the company to investigators, regulatory authorities, partners and shareholders.
- Manage a team of clinical development professionals responsible for designing clinical trials and executing the clinical strategy in support of drug development for early and late-stage drug candidates.
- Will be directly responsible for building, managing, and mentoring a clinical science team to support clinical development programs across therapeutic areas.
- Lead the Clinical Development team, including interactions with research, drug safety, development operations, biostatistics, commercial, regulatory, and other functions.
- Partner with Regulatory Affairs on the development of clinical and regulatory strategy and represent the clinical team in regulatory interactions.
- Partner with other research and development functions – Discovery, PreClinical, CMC, Commercial, Medical Affairs, Regulatory Affairs, etc. on the development and refinement of the Target Product Profile and commercialization strategy throughout the product life cycle.
- Ensure adherence to GCP/ICH standards and internal SOPs in the conduct of clinical trials.
- Responsible for the clinical development plan for all clinical development programs.
- 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.
- Working with the Senior Vice President & Chief Medical Officer, may partner with business development on the evaluation and in-licensing/acquisition of external product development opportunities in alignment with the company’s focus in establishing a first class and diverse product development portfolio.
- Support the company in establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- MD with 10 – 15 years’ relevant experience in the pharmaceutical or biotechnology industry with emphasis on vaccines.
- Broad and extensive clinical development experience across all phases of vaccine product development.
- Proven successful track record in leading and managing high performing teams to obtain regulatory approval in the US and EU is preferred.
- Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines in vaccines are essential as well as knowledge of ex-US regulatory processes.
- Experience in the design and conduct of global vaccine clinical trial programs.
- 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 with an entrepreneurial spirit.
- Proven success in executing clinical development strategies, identify core issues and obstacles for the clinical development of a designated indication, and to critically evaluate outside expert advice.
- Demonstrated consistent achievement of team delivery against commitments and goals.
- Proven experience in recruiting and managing high performing talent in the vaccine field.
- Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies.
- Possess 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.
- Excellent verbal and written communication skills.
- Strong scientific writer and oral presenter.
- Experience with communication of company goals and objectives to investors and partners.
- Courage to be an “out-of-the-box” thinker, to take on calculated risks, and champion new ideas and approaches for the advancement of a broad vaccine product portfolio.
Dynavax is an equal opportunity employer.