Vice President, Medical Affairs
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 will oversee and lead the Medical Affairs function for the company, ensuring that the organization develops and implements strategies that are consistent with the role of a Medical Affairs organization, reflect changes in the medical and regulatory environment, and are aligned with the company’s long-term strategic and financial goals. The position will ensure the Medical Affairs function works collaboratively with other functions within the company including policy and government affairs. In addition, the incumbent will develop and/or implement overall strategy relating to hospital, medical, and health planning issues.
The VP of Medical Affairs will maintain positive professional relationships with the medical community, especially in the company’s specific discipline/product line to identify future business opportunities and emerging medical and health care practices. The VP will facilitate and/or deliver scientific/medical exchanges of information, or clinical and research findings of products through symposia, lectures and publications.
- Lead the Medical Affairs Department, fostering a positive organizational culture by promoting the values focused on patients, science, internal and external stakeholders.
- Leverage medical insights from internal and external stakeholders into strategic product/ brand and medical plans to support scientifically appropriate product messaging.
- Provide clinical expertise to develop a strong communication and medical information platform.
- Oversee the design and oversight of Phase 4 and other post-approval studies.
- Collaborate with Clinical Development to support product development.
- Provide scientific expertise in the evaluation of investigator-initiated research proposals.
- Support the company in establishing and maintaining a work environment focused on quality, compliance and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Oversee Medical Communications & Publications to develop training materials; provide ongoing disease state and product- specific training to the US cross-functional team, as needed.
- Oversee Medical Information and the development of science-based responses to inquiries from providers and others.
- Partner with Commercial, Marketing, Market Access, Patient Advocacy, policy, and government affairs teams to identify data gaps and shape Dynavax’s strategic platform.
- In collaboration with project, communications and publication teams, develop scientific platforms for differentiation of Dynavax’s portfolio versus competition.
- Maintain knowledge and clinical expertise in relevant therapeutic areas; attend national and international congresses; enable peer-to-peer scientific exchanges to advance the knowledge and understanding of HEPLISAV-B and early development therapeutic areas.
- Contribute to development and review of preclinical/ clinical sections of regulatory documents for US regulatory submissions, as needed.
- Organize and lead/attend Medical/Scientific/Clinical Advisory Board meetings, satellite symposia and other medical programs, in collaboration with the Clinical Development team.
- Build and maintain outstanding relationships with thought leaders, researchers and experts in hepatitis, other infectious disease areas, and vaccines, when appropriate.
- Establish scientific exchanges with key opinion leaders in relevant pipeline therapeutic areas, in compliance with company and local industry regulations.
- Other duties as assigned.
- MD degree required.
- Preference will be given to candidates with clinical experience in infectious diseases.
- Must have 10+ years of demonstrated expertise and leadership in Medical Affairs, Clinical Affairs or related role in biotechnology/ pharmaceutical industry, preferably in infectious diseases.
- Successful track record in developing, leading and inspiring Medical Affairs teams.
- Motivates others to succeed and challenges teams to realize their full professional potential in order to achieve outstanding business results and accomplish corporate goals.
- Expertise regarding applicable compliance requirements.
- Proven leadership in KOL engagement and advocacy building, preferably in hepatitis other infectious diseases.
- Experience in strategic and tactical planning for marketed and pipeline products.
- Understanding of clinical research-related disciplines (e.g. biostatistics, regulatory, pharmacology).
- Strong scientific, analytical and problem solving skills, strategic thinking capabilities, project management, planning and organizational skills and excellent communication and presentation skills.
- Strong leadership capabilities, collaborative spirit and dedication to team accomplishments, perseverance to overcome short-term challenges and accomplish long-term objectives.
- Demonstrated capabilities to foster global collaboration and perform successfully in a multi-cultural cross-functional matrix environment.