Apr 06, 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 of PCS Toxicology Models 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 early development of new molecular entities (NME’s). You will have direct responsibility for the in vivo toxicology group encompassing both range-finding and investigational toxicology and an in vitro group covering 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 be to span both investigational and compound profiling in the discovery of new molecular entities. You will be leading a diverse group of scientists in the design and implementation of toxicology models for predictive and mechanistic translational toxicology and for leading global strategic initiatives in nonclinical support of innovative medicines. You will be responsible for the development of new models and methods for safety evaluation of experimental drugs. 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 be to:

 Build and lead a high performing team with interdependencies and close connectivities between within PCS to maximize PCS’s ability to ensure novel molecules are profiled and selected for development effectively. Your span will cover target identification, de-risking of novel mechanisms of action through to the selection of new molecules and responding rapidly with back translational strategies to support clinical findings as needed.
 Responsible for evolving a forward-looking strategy for the Toxicology Models group. Provides strategic oversight for the PCS Toxicology Models group to design and lead appropriately compliant and scientifically relevant studies to assess nonclinical safety that addresses theoretical and identified issues; integrate, interpret, and present results of nonclinical investigative safety studies including impact to drug development and / or project timelines; recognizes the importance of quickly addressing the key investigations so as to rapidly get treatments to the clinic identify and communicate potential safety issue resolution plans.
 Achieves and maintains high scientific and operational standards. Is a key stakeholder to build global strategy with department leader; acts as a senior member of leadership team and decision boards. Ensures optimal efficiency and powers an innovation engine through the evaluation of emerging trends in area of expertise and/or progression of new projects, technologies and/or partnerships through high functioning teams.
 Establishes mid‐ and long‐term scientific, technology and culture goals, plan of action and implementation within own direct team and/or cross‐functional matrix community. Achieves a culture of high performance and trust. Ensures the most talented associates in the industry are hired, developed and retained across the global department.
 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.
 Supports the PCS in the preparation and presentation of investigative non-clinical safety data in internal and external regulatory documents.
 Develop strategies for bringing in state of the art molecular techniques, such as genome engineering, and apply them to prospective and retrospective in vivo and in vitro evaluations of drug safety. Implement state-of-the-art and innovative toxicology models for drug safety assessment of targets and molecules. Lead a diverse group scientists / toxicologists in the design and implementation of toxicology models for Translational Toxicology and direct support of studies leading to the initiation of clinical trials, achievement of registration for drug candidates, and competitive safety analysis.
 Accountable for the overall scientific integrity and timely reporting of data generated in the group to ensure timely characterization and selection of NCE’s.
 Accountable and passionate for talent development and overall people strategy within the Toxicology Models group in Translational Toxicology including attracting key external talent, mentoring and career development.

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:

Ideal Background:

Education (minimum/desirable): 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

Languages: Fluent English (oral and written)

Experience/Professional Requirement:
- 10+ years of experience in leading an in vivo/in vitro laboratory with demonstrated experience in:
- Advanced pharmacology / toxicology and molecular / cellular biology-based laboratory approaches for the development of in vivo / ex vivo disease models
- In vivo genetic modification techniques including gene editing (constitutive / inducible gene knock-down / knock-out / knock-in; humanization)
- In vivo/ex vivo cell transfer and tracking techniques, in particular for immune cells
- An understanding of the drug development process and how investigative science plays a role in quickly and efficiently addressing key questions.
- Nonclinical safety issue resolution
- Communication and negotiation with global health authorities

This leadership role will be located in Cambridge, MA and requires a minimum of 3 days per week on site (subject to any Covid related restrictions) with up to no more than 2 days per week designated for remote work.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.

769 million lives were touched by Novartis medicines in 2020, 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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Translational Medicine
Cambridge, MA
Research & Development
Full Time
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Head, PCS Toxicology Models (Cambridge, MA)

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