Management and administration of cloud based applications (Dotmatics, Concur, Netsuite, PointPurcahsing, Cobblestone, Silkroad, ADP, Google Apps, Amazon and Google Cloud, Sophos, Global Meet, ADP, Azure, Okta and other company cloud services).
Work closely with the discovery research team to develop a pharmacodynamic biomarker plan, address the mechanism(s) of action require for efficacy, and identify and address key gaps in the pre-IND data package
Collaborate with the VP of Clinical Development, Chief Medical Officer, product team leads and cross-functional team members as needed to devise and maintain clinical development strategy for one or more NGM assets
Provides opinion and suggestions to the Executive Team with regard to the strategy and planning of the Bioanalytical work at the company. Be responsible for the design, execution and interpretation of bioanalytical assays. Scientific expert who contributes to responses to questions from regulatory agency on bioanalytical assays and immunogenicity. This may be achieved by collaborating with different disciplines and across cross functional teams.
Represent CLD functional area within the CMC team; communicate and collaborate with members from CMC, QA, Regulatory Affairs, Clinical Development within NGM and with CMOs and CROs to achieve project goals and timelines
Identify, recommend and implement opportunities for streamlining team and business processes; partner with the team leader to ensure the team achieve and maintains a high-level of sustainable performance, by applying appropriate team management best practices.
Design, plan, monitor and conduct preclinical pharmacokinetic studies to support drug candidate nomination and early preclinical drug development activities in-house and at contract research organizations.
Maintain good record keeping of laboratory work in notebooks; organize, analyze, and
write up data in presentations and reports; support process development for drug product fill/finish operations at CMO.
Provide technical oversight on all upstream related activities including process development, process transfer and cGMP manufacturing; responsible for planning, coordinating and managing the activities of the Upstream sub-function within CMC.
Design, build and screen yeast or other display libraries to discover therapeutic antibodies; optimize therapeutic antibodies through humanization, affinity maturation and manufacturability engineering.