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Safety Assessment Expert, Immunology Therapeutic Area (PCS)

Closing date
Sep 27, 2023

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Pharmaceutical, Pharmacovigilance
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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, with focus on Immunology portfolio, and will be located at the Novartis Institutes for Biomedical Research (NIBR) site in Basel, Switzerland.

Your responsibilities will include but not be limited to:

• Represent PCS on project teams of a wide variety of therapeutic modalities, with focus on immune-modulatory drugs within Immunology and Immuno-Oncology portfolio. 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.
• Lead design and execution of “fit for purpose and modality” nonclinical programs for complex therapeutic principles (eg complex Biologics, CAR-T therapeutics) 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.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you will bring to the role:

Required: A PhD in Pharmacology, Toxicology or a related biological science (particularly Immunology, Cell / Molecular 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); demonstrated scientific and regulatory experience in the immunosafety field.
• 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 Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

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