Safety Assessment Expert, Multiple Therapeutic Areas (PCS)

379807BR

Job Description

5600! That's the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. Translational Medicine (TM) plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application.

In the role of Safety Assessment Expert you will be part of the Preclinical Safety (PCS) group within TM supporting a variety of therapeutic areas and will be located at the Novartis Institutes for Biomedical Research (NIBR) site in Cambridge, MA.

Your responsibilities will include but not be limited to:

* Represent PCS on project teams of a wide variety of therapeutic modalities and assure appropriate design and execution of nonclinical safety assessment plans to meet team objectives and that the PCS support to all assigned projects is optimal in quality, timing and cost.
* Assemble and lead Target teams to ensure appropriate PCS input to project plans and appropriate resource planning within PCS; oversee nonclinical strategy to enable initiation of clinical trials and achievement of registration for drug candidates.
* Recognize the need for a "fit for purpose and modality" nonclinical program as needed and collaborate with line functions outside of PCS to accomplish this goal.
* Communicate effectively and in a timely manner to PCS and project teams regarding the theoretical or observed safety effects, their impact and proposed plans to address them, resource requirements to execute nonclinical safety assessment plan. and clear, concise and correct communication of nonclinical safety results and their impact to Health Authorities and investigators.
* Work closely with the PCS Therapeutic Area Head for alignment with PCS Therapeutic Area Strategy Teams, PCS line functions and NIBR/Novartis Development project/program teams in managing the preparation and presentation of nonclinical safety data in internal and external documents (e.g. Investigator's Brochure, IND, CTD, IMPD, Health Authority briefing books) and in negotiation with Health Authorities. Evaluation of in-licensing opportunities and due diligence upon request.

The pay range for this position at commencement of employment is expected to be between $183,200 and $274,800/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 will be located at our Cambridge, MA site and will not have the ability to be remotely located.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 tas.nacomms@novartis.com 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.

Division

Novartis Institutes for BioMedical Research

Business Unit

Translational Medicine

Country

USA

Work Location

Cambridge, MA

Company/Legal Entity

NIBRI

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No