Mar 10, 2022

Job Description

6000! 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. The Pre-Clinical Safety (PCS) group in NIBR provides world class preclinical safety profiling and assessment for optimal drug discovery, development and registration, with state-of-the-art regulatory compliance.

As the Head, PCS Scientific Study Monitoring within Translational Toxicology in Preclinical Safety (PCS), you will lead a team both directly and through matrix leadership to effectively design and execute strategies for the development of new molecular entities (NME’s). You will have direct responsibility for the Study Monitor group encompassing all types of in vivo toxicology studies conducted at CRO’s across the multiple disease areas of the NIBR project portfolio. You will impact all disease areas of NIBR through the design, conduct, reporting and review of these studies. You will have the opportunity to span from early research and throughout the entire development life-cycle of new molecular entities with responsibility for GLP and non-GLP studies. You will impact the entire Novartis portfolio through your leadership of a group of study monitors that cover all areas of toxicology (dose-range finding, sub chronic, chronic, carcinogenicity and DART) and modalities (small molecule, biologic, gene and cell therapy, etc.) touching on every project and leading global strategic initiatives in nonclinical support of innovative medicines. You will write and/or review toxicology sections of regulatory submissions and you will interact with regulatory agencies (FDA; EMEA) in support of Novartis projects. You will connect Novartis with external collaborators to deliver new, innovative medicines.

Your main accountabilities will not be limited to:

 Responsible for evolving a forward-looking strategy for Study Monitoring. Provide strategic oversight for the PCS Study Monitors in Translational Toxicology by working directly with PCS Target Teams and NIBR / Franchise project teams to design and lead appropriately compliant and scientifically relevant studies to assess nonclinical safety through the management of outsourced nonclinical studies – both GLP and non-GLP; integrate, interpret, and present results of nonclinical safety studies including impact to drug development and/or project timelines; recognizes the importance of quickly addressing the key issues so as to rapidly to get drugs to the clinic and communicate potential safety issue resolution plans. Your span will cover early dose range finding through all phases of drug development including sub chronic, chronic, carcinogenicity and DART studies.

 Leads a cross‐disciplinary team and brings together a broad functional community. Serves on PCS leadership teams and/or decision boards to review projects and programs, assess progress, and provide multi‐directional input to progress the PCS project pipeline; shares and communicates key information to team. Drives continuous improvement and provides deep insight with collaborators within area of expertise, and / or works with own team to build scientific, technical or early development expertise and added value within department and across NIBR.

 Works closely with outsourcing teams to ensure optimal placement of studies to support the rapid development of Novartis drugs and works with operations to ensure appropriate coverage of all outsourced studies.

 Supports PCS Target Teams to assure (i) alignment with Therapeutic Area Strategy Teams and NIBR / GDD project / program teams and (ii) manages communications and builds relationships between internal PCS line functions and other NIBR and Novartis line functions such as research staff in the relevant Disease Areas, Drug Regulatory Affairs and TRD (Technical Research and Development).

 Play an integral member of the Translational Toxicology Leadership Team with shared strategic and operational ownership for the overall success of global Translational Toxicology in assessing the safety of novel molecules.
 Build strong partnerships and, through matrix
leadership, bring together a diverse team to effectively execute a strategy of drug development.

 Accountable for the overall scientific integrity and timely reporting of data generated in outsourced toxicology studies to ensure timely characterization and selection of NCE’s.
 Accountable and passionate for talent development and overall people strategy within in vivo Translational Toxicology including attracting key external talent, mentoring and career development.

Position can be based in East Hanover, NJ, Cambridge, MA or Basel, Switzerland.

Diversity & Inclusion / EEO

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: PhD in pharmacology, toxicology, immunology, molecular biology, cell biology or a related biological science; MD, DVM, PharmD or equivalent with a strong in vivo, molecular and cell biology background.

Experience/Professional Requirement:

- 10 plus years of experience in leading running GLP and non-GLP Toxicology studies
Experience with all phases of drug development and ICH guidance’s driving the development of
- Demonstrated leadership in cross-industry organization
- An understanding of the drug development process and how toxicology plays a role in quickly and efficiently developing drugs.
- Nonclinical safety issue resolution
- Communication and negotiation with global health authorities

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!

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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Translational Medicine
East Hanover, NJ
Research & Development
Full Time
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Head, Scientific Study Monitoring (CAM, EH or Basel)

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