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Principal Scientist : Global Drug Discovery
Location:
Lexington, MA
Description:
About the Department Our US Research and Development (R and D) hub, located in the Greater Boston area, brings together the best talent to drive life science innovation, from early research through late:stage clinical development. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R and D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients. Global Discovery and Development Sciences (GDDS) Boston, part of the US R and D hub, is building a new siRNA Nonclinical Development department with cross:functional scientific expertise, including toxicology, safety pharmacology, PKPD, ADME, outsourcing management, and non:clinical project management. The department manage the nonclinical development process from lead candidate selection to submission and registration of new siRNA:based therapies within our core business areas, including diabetes, obesity, cardiovascular disease, metabolic dysfunction:associated steatohepatitis and chronic kidney disease, and rare diseases. Our proprietary GalXC(TM) and GalXC:Plus(TM) siRNA technologies have the potential to selectively target and modulate proteins that cause or contribute to the disease and thereby address conditions that are difficult or impossible to treat with other modalities. The team is located in Lexington in close proximity to our Discovery and Development teams to facilitate collaboration and knowledge transfer throughout the lifecycle of a project. About the Position Our new growing siRNA Nonclinical Development department is looking for a Principal Toxicologist to provide scientific leadership and be responsible for the siRNA nonclinical development toxicology strategy and its implementation. The Principal Toxicologist will be part of a highly ambitious multi:disciplinary team dedicated to challenge and optimize the way we do siRNA nonclinical development to ensuretimely and adequatenonclinicalregulatory documentation, safety assessments, and clinical trialsupport for our siRNA projects. The Principal Toxicologist will be responsible for the design and execution of nonclinical development toxicology studies conducted externally, interpretation and communication of the toxicology data/reports to support drug development decisions, and for summarizing and writing regulatory submissions. The Principal Toxicologist will work closely with the Nonclinical Study Managers which will help to oversee and manage the outsourced nonclinical studies (non:GLP and GLP).We are looking for an individual that can challenge status quo and has proven ability to optimize and design tailor:made toxicology and nonclinical activities to support our growing siRNA project portfolio. Relationships Reports to Head of Global Discovery and Development Sciences Boston. Relationships include working in a multi:functional department with various nonclinical disciplines, including other toxicologists, interaction with external research collaborators (mainly industry:based), and frequent interaction with nonclinical project managers and other colleagues across global R and D. Essential Functions stylemargin:bottom:11.0px::Design study protocols and execute external non:GLP and GLP nonclinical development toxicology studies:Work closely with Nonclinical Study Managers to oversee and manage the outsourced nonclinical development toxicology studies with regards to deliverables, timelines and budgets:Review and communicate toxicology data/reports to support drug development decisions:Writing and preparation of nonclinical components for regulatory submissions (e.g. IB, pre:IND, IND/CTA and NDA/MAA):Participate in development and continuous optimization of our nonclinical development toxicology strategy:Provide re
Posted:
May 1 on Tip Top Job
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Principal Scientist : Global Drug Discovery is a Science & Pharmaceutical Scientist Job located in Lexington MA. Find other listings like Principal Scientist : Global Drug Discovery by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Principal Scientist : Global Drug Discovery is a Science & Pharmaceutical Scientist Job located in Lexington MA. Find other listings like Principal Scientist : Global Drug Discovery by searching Oodle for Science & Pharmaceutical Scientist Jobs.