Serve as member of discovery leadership, direct portfolio, and manage resources for target discovery and early stage projects; translate the company's research strategy into functional plans, processes and practices to deliver research consistent with standard operating procedures.
Collaborate with protein engineers and other scientists to support structure- and property-based design of therapeutic proteins and antibodies; design novel fusion proteins, multispecific antibodies, and linker sequences that will be incorporated into candidate medicines.
Collaborate with Denali scientists and contract manufacturing organizations to generate biotherapeutics for pre-development research and lead selection; evaluate and recommend Cell Line Development technologies and contract manufacturing organizations to ensure the successful development of lead biotherapeutics.
Develop Clinical Pharmacology study designs and write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
Responsible for the design, execution, analysis, interpretation and presentation of clinical and translational studies; participate in the development and execution of strategies for new product development and lifecycle growth, including regulatory and investigator interactions as applicable.
Organize, manage, and drive CMC strategies, plans, and deliverables for small molecule and biologic drug candidates from the research, pre-IND, and first-in-human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.