Director, Medical Information And Compliance

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens. HIL-214 has been studied in eight Phase I/II studies in more than 4,500 subjects. HilleVax is currently planning initiation of a Ph 2b study in infants.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The Medical Information Director is a key member of the Medical Affairs leadership team contributing with both subject matter expertise on the disease/product as well as up to date knowledge on Medical Information & Material review best practices. Key activities for the role include the building of Medical Information and Compliance as a function, developing high quality MI content based on current standards, ensuring the implementation of the Medical Materials review and approval process, partnering with commercial colleagues in creating scientifically accurate and compliant material, developing training material, supporting congress presence etc

Responsibilities:

• Develop strong product and disease expertise and maintain knowledge base

• Build Medical Information related tools and processes

• Responsible for building and maintaining a knowledge base including among others customized and standard response documents, FAQs etc

• Ensure responses to unsolicited enquiries are delivered in a timely manner and are developed based on highest scientific and process standards

• Coordinate review of Medical Information documents

• Maintain relevant electronic tools and platforms

• Develop training material (e.g. literature alerts) and offer training to internal teams as needed

• Establish the development of metric reports/dashboards on a regular basis and present as needed

• Support congress presence by capturing MI queries, developing congress specific FAQs, scientific intelligence, booth staffing etc

• Build strong cross-functional working relationships (clinical development, pharmacovigilance etc)

• Leads the Medical Materials Review Process and ensures relevant material comply to industry and other standards

• Serve as medical reviewer for medical and promotional material

• Collaborate with commercial in building scientifically accurate, compelling and compliant with current standards promotional campaigns

• Maintains up to date knowledge of FDA guidance and standards as well as relevant to HilleVax geographies

• Manage budget and vendors

Education, Experience & Skills:

• Advanced scientific degree (PharmD, Ph.D.)

• 8 (director/ Sr director 12 plus) years of experience in medical affairs of which at least 4 in Medical Information

• Excellent working knowledge of Global rules and regulations governing Medical Information and Review

• Experience in vaccines is a plus

• Attention to detail

• Demonstrated cross functional collaboration skills

• Creative, results-oriented, resourceful

• Ability to manage time and resources effectively

Travel, Physical Demands & Work Environment:

• Up to 20% - congress related

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.