Study Monitor - Principal Scientist Novartis in US National

Overview

The Preclinical Safety (PCS) department within the Biomedical Research (BR) - Translational Medicine Unit provides non‑clinical safety strategy of products in discovery, development and market, globally, with state‑of‑the‑art regulatory compliance. As a Scientific Study Monitor, you will join our PCS team to oversee non‑clinical research activities for multiple projects across multiple disease areas for in‑vivo toxicity and/or in‑vitro screening toxicity studies conducted at our CRO partner sites as per the internal strategy and international standards, acting as the primary scientific contact for the Study Director.

• Formulates and leads/co‑leads novel projects with team or enables matrix collaboration on project/technology solutions to achieve creative results for impact on   goals. Generates innovative ideas within own team and/or project team/functional community to meet new technical requirements and/or answer project key scientific/technical/development questions. Establishes target dates and priorities to enable data‑driven advancements in project teams, within own team, and with collaborators, or within functional community.
• The Study Monitor is appointed to each outsourced preclinical study based on relevant technical expertise, designated disease area and/or scientific background knowledge and acts as the primary scientific contact for the Study Director at the Contract Research Organization (CRO).
• The Study Monitor is responsible for overseeing the progress of the study and for ensuring that the study is conducted, recorded and reported according to the study protocol. The Study Monitor should ensure that the study is compliant with the appropriate GLP regulations, Novartis animal welfare policies, CRO in‑house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
• Resolution of study related issues, liaisons with internal experts and informing the appropriate people in a timely manner is pivotal to the performance of this role. The study phases and sample delivery timelines should be strategically overviewed and tracked to ensure that internal contributor reports are delivered to the CRO on time and that the CRO meets its agreed main reporting timelines.
• Communication skill is critical to this role in forming strong working relationship with other Target team members.
• Works closely with the PCS‑Operations and PCS Project Team Member (PTM) to formulate a project outsourcing strategy.
• Has a working knowledge of HA regulations (Swiss medic, OECD, FDA) to support conduct of GLP compliant toxicology studies.
• May be PCS part‑time PTM.

• PhD or MVSc/MS/M.Pharm with 7+ years of experience in drug discovery and/or development, preferably as Study Director or Study Monitor in the early preclinical screening and GLP studies.
• In‑depth knowledge of toxicology assays in early development, Safety pharmacology and genotoxicity.
• Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
• Excellent communicators, strong team players and have a high level of logistical/planning ability.
• Registration and certification with one of the International Toxicology reg.

• Animal Models
• Bioinformatics
• Collaboration
• Communication Skills
• Data Analysis
• Ethics
• Laboratory
• Problem Solving
• Regulatory Compliance
• Research
• Risk Assessment
• Toxicology

Principal Scientist I: $119,700 – $222,300 per year.

Principal Scientist II: $126,000 – $234,00 per year.

The final salary offered is determined based on factors such as relevant skills and experience and is reviewed periodically. Compensation includes a performance‑based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. Eligible US employees receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a generous time‑off package including vacation, personal days, holidays and other leaves.

The Novartis Group of Companies is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

The Novartis Group of Companies is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation, please let us know the nature of your request and your contact information.