Novartis Pharmaceuticals Project Team Member, PK Sciences Ophthalmology Therapeutic Area (TA) in Cambridge, Massachusetts
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.
PK Sciences (PKS) is a global organization of about 300 associates, within NIBR, Novartis’s Research Organization. Although PK Sciences is part of NIBR, we provide nonclinical and clinical PK/PD/IG/ADME support to all stages of Drug Development, from the very early stages of Discovery through Post-Market for all modalities (LMW, Biologics, Cell Therapies, and Gene Therapies).
We are seeking a project team member to join the PKS Ophthalmology team at the Cambridge, MA location. As an individual contributor you will collaborate with other Line Functions to select and characterize new chemical and biologic ophthalmic drugs for advancement into the clinic, characterize their properties in clinical trials, and create documents for Regulatory submissions. In this role you will represent the PKS discipline on discovery and development project teams, contributing to the creation and implementation of the project-specific strategies and tactics. In addition to the development of Novartis’s own drugs, you will also participate in Due Diligence activities to evaluate potential external business opportunities.
As a Project Team Member within NIBR’s PK Sciences, OPHTHA TA you will have the unique opportunity to support clinical and nonclinical projects across the Drug Development continuum for multiple modalities and not be limited to supporting LMW or biologic drugs.
Your main responsibilities will include but not be limited to:
• Represent the PK/PD/IG/ADME discipline, and serve as the primary source of scientific expertise on global cross-functional project teams, leading the design, execution, and analysis of PKS nonclinical and clinical studies.
• Work with subject matter experts in PKS and partner groups, support the efficient application and integration of modelling and simulation tools to advance lead optimization, clinical candidate selection and dose selection.
• Support PKS components of nonclinical and clinical study protocols, nonclinical and clinical study reports, and documents for Regulatory Submission (e.g. Investigator Brochures, nonclinical PK and clinical pharmacology summaries etc). Participate in meetings with Health Authorities and contribute to Due Diligences.
• Collaborate with other NIBR and GDD functions, bring innovative ideas and approaches, and a leadership, enterprise mindset that inform and influence the overall drug discovery and development process.
Project Team Member, PK Sciences Ophthalmology Therapeutic Area (TA)
What you will bring to this role:
• PhD in pharmacology/physiology, biochemistry, chemistry, pharmacokinetics/pharmaceutical sciences, ophthalmology or related sciences.
• Good understanding of the drug discovery and development process, with a minimum of 3+ years in industry.
• Hands-on project experience in the development of LMW and biologics for the treatment of ocular diseases and with the development of drugs to be administered by ocular topical and intravitreal routes.
• Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidances desired.
• Excellent written and oral communication skills is a must.
WHY CONSIDER NOVARTIS?
799 million. That’s how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Research & Development
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