346048BR
Jun 16, 2022
USA

Job Description

450 projects straddle discovery through development. within PK Sciences @ NIBR. Do you want to be at the forefront of the fight against multiple diseases making 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 this opportunity to make an impact, PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within pharmaceutical industry, where one can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to apply the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and clinical development through approval and beyond. Novartis portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We are active in multiple therapy areas like Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic and Infectious diseases. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.

In this role of Sr. Principal Scientist, you will provide scientific expertise to drive the success of fully outsourced clinical pharmacology studies by implementing strategies to achieve timely delivery of good quality clinically pharmacology data to support clinical development programs across all therapeutic areas and for regulatory submissions. Collaborate with internal project teams, clinical trial teams, and external CRO partners serving as a PK expert and liaison to deliver the Phase 1 clinical pharmacology portfolio.

Major Accountabilities Include:

• Represents PK Sciences (PKS) group in the clinical trial teams (CTT) comprised of medical, biostatistics, bioanalyst, clinical scientists, regulatory experts, and clinical supply managers, formed under Phase 1 Clinical Pharmacology Department (Phase 1 CPD).
• Oversees outsourced PK activities of Phase 1 trials - FIH, DDI, BA/BE, Human Mass Balance, Hepatic Impairment, etc..
• Drives fully outsourced project team’s PK strategy. Works globally across all therapeutic areas.
• Provides PK scientific leadership and expertise to all line functions on the CTT under Phase I Clinical Pharmacology Partnership (Phase 1 CPP) model.
• Responsible for review and finalization of study related clinical documents including protocol, Statistical Analysis Plans (SAP), and Clinical Study Report (CSR).
• Lead the oversight of PK data analysis, data interpretation with CRO partners and communication of the results internally.
• Oversee publication and external presentation of study results.
• With support from PK Project Team Member (PK PTM) and Therapeutic Area Heads (TA Heads), participate in selection of studies to be conducted under Phase 1 CPP model according to clinical pharmacology and profiling plan for the project.
• Together with the PK PTM may represent PK Sciences on Global Project Team (GPT) communications.
• Act as an effective sponsor representative to external partners on PK related questions and issues.
• Able to work independently on study planning and execution, and with collaboration on project planning.


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

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:

Minimum requirements:
• PhD or PharmD in pharmacology/physiology, biochemistry, chemistry, pharmacokinetics/pharmaceutical sciences, or related sciences
• Extensive and in-depth knowledge of the clinical drug development process, with a minimum of 8 plus years’ industry experience in a pharmaceutical/biotech company, CRO, or related clinical research/trials experience
• Extensive and in-depth knowledge of pharmacokinetics, clinical pharmacology including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences
• Early clinical drug development experience in designing/conducting/PK analysis/data interpretation of Phase 1 trials (e.g. First in Human, drug interaction, food effect, relative BA, bioequivalence, and hepatic/renal impairment studies) is strongly preferred
• Hands-on project experience with low molecular weight and biologics modalities
• Familiarity with standard ADME/PK modelling tools such as Phoenix WinNonlin, GastroPlus, etc.
• Demonstrated success of working in a global matrix environment and with cross functional project teams
• Experience in authoring regulatory documents with knowledge of global regulatory requirements and guidance is advantageous
• Excellent written and oral (English) communication and negotiation skills
• Strong coaching, mentoring or people management skills are desired
• Experience in managing external relationships in a clinical research setting (with CRO)

Desirable skills:
• Track record of successfully managing multiple Phase 1 or clinical pharmacology PK trials concurrently

Why Consider Novartis?

766 million. That’s how many lives our products touched in 2021. 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.

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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network

We are Novartis. Join us and help us re-imagine medicine.
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NIBR
Translational Medicine
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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346048BR

Senior Principal Scientist, PK Sciences Phase 1 Clinical Pharmacology

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