NIBR’s global Translational Medicine group builds on basic research advances to develop new therapies that address unmet medical need. We are the crucial bridge between drug discovery and clinical application. The Preclinical Safety (PCS) organization within Translational Medicine provides world class preclinical safety profiling and assessment for optimal drug discovery, development, and commercialization with state-of-the-art regulatory compliance. We achieve this together with our internal partners as a global organization working in an environment of mutual trust and respect.
The preclinical safety organization is seeking an experienced Toxicologist with a high level of knowledge and experience in preclinical safety and DART (developmental and reproductive toxicology) studies to work independently within Preclinical Safety to contribute to the development and registration of Novartis products. You will have a sound scientific background in developmental biology and excellent understanding of developmental and reproductive toxicology study designs and overall drug development. In this role you may serve as a study monitor of complex contracted studies involving direct interaction with groups within and outside of PCS including PCS management, Study Directors, PTMs, NACUC members, NIBR Quality and various CRO personnel. You will also have the opportunity to mentor and train junior associates.
Your main accountabilities will include but not be limited to:
• Partner with PCS PTM (Project Team Member) on their programs as DART development plans or issues need to be addressed, including interactions with the health authority.
• Participate as an ad hoc member on Therapeutic Area strategic teams to address DART plans for portfolio.
• Participate in PCS target teams to address project DART plans
• Proactively maintain current knowledge of scientific and regulatory areas affecting drug safety issues worldwide including DART, GLPs, animal welfare regulations, and drug development process.
• Respond to Health Authorities (FDA; EMEA, etc) regarding questions and labeling discussions on DART issues
• Liaise with CRO’s on DART studies as Study Monitor and/or scientific expert in DART. You may also serve as Study Monitor to coordinate the monitoring/reporting of complex DART external studies. This includes facilitating effective communication between Study Director and Novartis PTM, Principal Investigators, etc., providing scientific input to study design, establishing study protocols, monitoring the study conduct and raw data, evaluating study data, and finalizing study reports on time.
• Maintain expertise in scientific field and knowledge of relevant regulatory guidelines.
• Write SOPS, internal guidance documents where appropriate.
• Participate in project teams/task forces as required.
• May be PCS part-time PTM and serve on target teams.
The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
This position is located at our East Hanover, NJ or Cambridge, MA site and will not have the ability to be located remotely.
Minimum requirements
What you will bring to the role:
Education:
Required: A PhD in Pharmacology, Toxicology or a related biological science (particularly Immunology, Cell Biology, Biochemistry and Virology) or an MD/DVM/ PharmD or equivalent with a strong background or equivalent work experience.
Desired Experience:
Demonstrated experience in the preclinical development of small molecule, biotherapeutics and/or gene and cell therapies and the safety issue awareness of these modalities.
• 8+ years experience in a nonclinical drug development scientific discipline (e.g. study director, project team toxicologist or pharmacologist).
• Awareness of global health authority guidance and expectations for nonclinical programs supporting regulatory applications.
• Experience in direct or written communication of strategy and data to global health authorities.
• Leadership in cross-industry organizations (discipline-related or related to drug development).
• Excellent interpersonal, leadership, organizational skills (e.g. planning and time management) and teamwork skills. Excellent oral and written communication and influencing skills. Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraints.
• Ability to focus and work on several projects simultaneously and to effectively manage conflicting expectations from the line unit, TA Strategy team and project teams in a matrix management environment.
• Customer focused thinking. Recognized ability to represent PCS on Novartis cross functional decision boards or other cross functional project teams.
• Recognized expertise in technical and scientific problem solving in a project driven, multi-disciplinary international environment.
• Ability to mentor and coach new Program Team representatives from PCS.
Why consider Novartis?
736 million. That’s how many lives our products touched in 2022. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities,join the Novartis Network here: https://talentnetwork.novartis.com/network.
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