Director, Vaccine Immunogenicity
Our Company's Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (PPDM) Department is seeking an exceptional leader who is passionate about leading a team of Scientists overseeing vaccine good laboratory practice (GLP) and clinical assays. As Director of the Regulated Immunogenicity Group, you and your team will work collaboratively with and participate on cross-functional development teams to enable pipeline decisions. The main responsibility is leading a group who analyzes GLP toxicology and clinical samples from vaccines studies. Additionally, the position requires a focus on talent development and external engagement with the scientific community in developing best practices for vaccine bioanalytics, including potentially an expanded scope into newer more complex modalities such as oncolytic virus, cell and/or gene therapy. The desired candidate must also show strong working knowledge of regulatory (clinical) immunogenicity and assay guidance and have experience in authoring and reviewing regulatory submissions and responses ( biologics license application submission). At our Company, we are transforming the role of bioanalytics to integrate program understanding, workflows, and data analytics across platforms and modalities as we develop the future generation of bioanalytical scientists. This role provides a unique opportunity to influence how we do vaccine bioanalysis, to develop future talent, and to enable decisions on novel vaccines for patients in need around the world. Responsibilities include, but are not limited to:
· Providing strategic, scientific, and operational leadership to the group responsible for providing GLP toxicology and clinical results for our vaccine trials.
· Actively working with staff to encourage and facilitate their personal and scientific development.
· Collaborating with leaders across our Company in the timely delivery of vaccines data.
· Serving as a representative of our Company in the external bioanalytical community.
· Setting future strategies and bringing new technologies into the labs.
· Responsible for scientific over-sight of outsourced vaccines bioanalytical work to Clinical Research Organizations (CROs) in collaboration with the PPDM Operations, Sourcing and Logistics group ensuring quality external data.
Education Minimum Requirements:
· Ph.D. degree in Immunology, Biology, Biochemistry, Molecular Biology, Virology, Pharmaceutical Sciences, Chemistry, or related area with 10+ years
· MS degree with 15+ years of relevant experience.
Required Experience and Skills:
· A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.
· Extensive knowledge of and hands-on experience in in regulated bioanalytical assay (LBA, PRNT, multiplexed) design, development, transfer and execution in support of vaccines for GLP and/or clinical development.
· Experience in interacting with and influencing development or cross-functional teams.
· Expertise in authoring and reviewing regulatory submissions and responses as well as experience interacting with Health Authorities including biologics license application (BLA) submissions.
· Ability to manage effectively a portfolio of projects and multi-task in a highly dynamic environment.
· Flexibility to work in a fast-paced environment in a professional and positive manner.
Preferred Experience and Skills:
· Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
· Proven ability to lead development of new, innovative approaches including experience with new assay or robotic technology evaluation and shaping scientific strategy both at the platform and program level.