349163BR
Jul 18, 2022
USA

Job Description

Novartis Institutes for BioMedical Research (NIBR),  San Diego, CA 

4 FDA approved drugs; 15+ clinical candidates; 400+ patents; 20 years of NIBR San Diego history! For over 21 years, NIBR - San Diego has been doing cutting-edge innovative drug discovery for Novartis global research organization.

Your responsibilities:

Do you want to be at the forefront of the fight against multiple diseases? Do you aspire to make an impactful contribution in bringing transformative therapies to patients, and be part of Novartis’ mission to reimagine medicine to improve and extend people’s lives?

PK Sciences (PKS) offers you a unique opportunity in San Diego to contribute to the development of novel therapeutics, including small molecules, tissue-targeting siRNA, antibody and bioconjugates.

PK Sciences (PKS) is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of NIBR. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science works across both NIBR and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.

In the role of Principal/Senior Principal Scientist, you will collaborate with a cross-disciplinary team to select and characterize new chemical and biologic entities in research and development and implement clinical pharmacology strategies in early and late clinical development. You will represent the PK/PD/ADME discipline on discovery and development project teams, as well as suggest and implement strategies and tactics to advance high-quality entities as part of the overall program(s).

Major accountabilities include:

As a project team member you will guide complex modality projects (biologics, siRNAs etc) from molecular design into clinical development.

In this role you will provide matrix leadership to collaborate, align and influence the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences discipline (PK, PK/PD, metabolism and clinical pharmacology).

You will lead the strategy, design, execution, and analysis of PKS preclinical and clinical studies

You will author preclinical and clinical study protocol designs, preclinical and clinical study reports, investigator brochures, IND, NDA etc.

You will prepare for Health Authority calls/meetings/discussion and be responsible as the PKS representative in these settings.

You will collaborate across Novartis and bring innovative approaches to project teams to accelerate the overall drug discovery and development process.

Evaluate in-licensing opportunities and carry out Due Diligence activities as required.

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:

Ph.D. / Pharm.D. with relevant experience in drug metabolism, pharmacokinetics and clinical pharmacology, or a related biologic background.

0-3+ years of experience in pharmaceutical industry in a field related to PKS (e.g. Drug Metabolism and Pharmacokinetics).

Hands-on project experience with large molecule (monoclonal antibody) and/or oligonucleotide therapeutic modalities.

Familiarity with standard ADME/PK/PD modelling tools such as Monolix, Phoenix GastroPlus, etc.

Proven record as team player/leader with superior communication skills.

Demonstrated success working in a matrix environment.

Excellent written and oral (English) communication skills.

Position will be filled at level commensurate with experience.

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!

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants…

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
NIBR
Translational Medicine
USA
San Diego, CA
Research & Development
Full Time
Regular
No
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349163BR

Principal/Senior Principal DMPK Scientist, PK Sciences

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