Senior Scientist - Toxicology

About 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 GalXC™ and GalXC-Plus™ 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.

 

The Position

Our new growing siRNA Nonclinical Development department is looking for a Senior Toxicologist to provide scientific leadership and be responsible for the siRNA nonclinical development toxicology strategy and its implementation. The Senior Scientist- Toxicology 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 Senior 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 Senior 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

• 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

• Bachelor 's Degree with 18+ years’ relevant experience, or a master’s degree with 12+ years’ relevant experience, or a Doctoral degree with 6+ years’ post-doctoral and/or industry relevant experience can be considered
• Advanced degree or PhD in toxicology or a closely related field of study