- 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 regular updates to internal stakeholders/project teams on the progress of nonclinical activities
- Ensure that all nonclinical activities are performed in compliance with company policies, procedures, and regulatory requirements
- High focus on 3R principles (Replacement, Reduction & Refinement)
- Occasionally participate in evaluations of external opportunities and being part of a nonclinical Due Diligence team
- May participate in CRO evaluation or site visits Physical Requirements
- 0-10% overnight travel required. Qualifications
- Advanced degree or PhD in toxicology or a closely related field of study (pharmacology or veterinary medicine); DABT and/or DVM degree will be an advantage
- +10 years of experience within toxicology study design, execution and analysis, or equivalent knowledge through relevant practical experience
- In-depth experience with designing, conducting, and evaluating non-GLP and GLP non-clinical studies within toxicology and/or safety pharmacology, preferably with experience with siRNA/oligonucleotides
- Experience in communication with health authorities and in preparing regulatory filings, such as IB/IND/CTA/IMPD/NDA
- Demonstrates excellent verbal and written communication skills, with the ability to effectively present data and conclusions to diverse audiences
- Ability to navigate and be successful in a fast-paced, highly networked and project-driven environment with frequent course corrections and changing deliverables and timelines
- Capability to manage multiple vendors and projects simultaneously We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
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Principal Scientist - Lexington, United States - BioSpace
Description
Job DetailsAbout the Department
Our US Research & Development (R&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&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&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 GalXCTM and GalXC-PlusTM 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 ensure timely and adequate nonclinical regulatory documentation, safety assessments, and clinical trial support 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&D.
Essential Functions
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
