Translate the company's research strategy into functional plans, processes and practices to deliver research consistent with standard operating procedures; establish research priorities, resourcing and scientific outcomes to best manage direction of biology function.
Collaborate with protein engineers and other scientists to support structure- and property-based design of therapeutic proteins and antibodies; acquire or develop computational tools for predicting liabilities and biophysical properties that impact in vivopharmacokinetics and manufacturability.
The successful candidate will help conduct and manage both internal and external studies, contracting with CRO partners as needed; s/he will write, edit, and finalize appropriate sections of regulatory filings, and play a role in interactions with global health authorities.
Collaborate with scientists in Biology Discovery and Translational Sciences to optimize and characterize lead therapeutic vectors and generate material to support in vivo and in vitro efficacy studies.
Supports investigational new drug applications (IND), ex-US clinical trial applications (CTA), new drug applications (NDA/BLA/MAA) and related correspondence from the US Food and Drug Administration (FDA) and other global regulatory authorities.
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.
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.