Senior Scientist II - Non-clinical Safety

Novo Nordisk•Lexington, MA

51d

About The Position

The Senior Scientist II will be responsible for strategy implementation and operations for conducting and summarizing non-clinical safety studies internally and externally on new drug substances. Designs toxicology, safety pharmacology and toxico-pathological investigations in line with relevant GxP requirements in non-clinical development programs. Studies the safety related effects of biological and chemical entities in in vitro systems and animals and conducts non-clinical safety investigations on experimental drugs and other substances relevant to drug development. Develops and improves in vitro and in vivo methods for non-clinical safety evaluation, analyses and prepares reporting of findings, performs advisory functions and communicates evaluations and implications of non-clinical safety findings. Prepares and reviews non-clinical safety sections of regulatory submissions as relevant. Demonstrates subject matter expertise. Requires in-depth knowledge and experience. Solid knowledge and skills relevant for NN Business cross-functional understanding. Strong knowledge within a specific process and extensive business understanding across SVP area. Uses best practices and knowledge of internal or external business issues to improve products or services. Works independently; receives minimal guidance. Acts as a resource for colleagues with less experience; may direct the work of other staff members. Perceived as expert within one or several key processes across the VP/CVP area. Handling specialist tasks of high complexity critical to the CVP area. Lead multiple projects as subject matter expert, function as project leader for projects comprising multiple experimental activities & coordination of activities to meet deadlines, communicate project updates & experimental results, provide expert-level guidance to experimental plans & data interpretation; may propose & lead external research efforts to support project goals; attend & present at scientific conferences as an NN-subject matter expert; deep understanding of subject matter & demonstrate creative thinking & solutions for addressing critical scientific questions; may supervise junior staff; author internal reports & external publications; recommend, present, & champion new targets or methodologies. Demonstrated ability to map out long-term work plan to address gaps with an understanding of the bigger picture of drug development & needs within a therapeutic area or target biology space. May mentor or directly supervise less experienced team members based on business need, skill, and/or interest.

Requirements

BS/BA with 12+ years of relevant experience; or master’s degree with 10+ years of relevant experience; or PhD with 6+ years’ of relevant experience required
Demonstrates subject matter expertise in non-clinical safety evaluation
Applies solid knowledge and skills relevant for cross-functional understanding within the business
Uses best practices and knowledge of internal or external business issues to improve products or services
Works independently with minimal guidance, handling specialist tasks of high complexity
Analyzes and prepares reporting of findings, performing advisory functions and communicating evaluations
Prepares and reviews non-clinical safety sections of regulatory submissions
Designs and improves in vitro and in vivo methods for non-clinical safety evaluation

Nice To Haves

May supervise junior staff
Author internal reports & external publications
Recommend, present, & champion new targets or methodologies
Demonstrated ability to map out long-term work plan to address gaps with an understanding of the bigger picture of drug development & needs within a therapeutic area or target biology space
May mentor or directly supervise less experienced team members based on business need, skill, and/or interest

Responsibilities

Lead Non-Clinical Safety Studies
Design and oversee toxicology studies in line with GxP requirements (including clinical pharmacology, safety pharmacology, and histopathological endpoints)
Conduct and summarize non-clinical safety studies
Ensure the application of best practices and innovative approaches to improve study outcomes
Analyze and Report Safety Findings
Analyze data from in vitro and in vivo safety evaluations to assess the safety-related effects of biological and chemical entities
Prepare comprehensive reports of findings and communicate evaluations and implications to relevant stakeholders
Provide expert advisory functions on non-clinical safety findings to support decision-making processes
Regulatory Submission Preparation
Prepare and review non-clinical safety sections of regulatory submissions, ensuring compliance with relevant guidelines
Collaborate with cross-functional teams to integrate safety data into regulatory documents
Act as a subject matter expert in discussions with regulatory authorities regarding non-clinical safety data
Strategic Improvement and Innovation
Utilize in-depth knowledge and experience to identify opportunities for process improvements and innovation in non-clinical safety evaluations
Implement strategies to enhance the efficiency and effectiveness of safety studies and reporting
Stay abreast of industry trends and advancements to maintain a competitive edge in non-clinical safety practices