Sr. Principal Scientist, PKS, NITD

☞ Novartis Institutes for BioMedical Research (NIBR)

看过: 167

更新日: 26-03-2024

位置: Basel Basel-Stadt BS

类别: 教育/培训

行业: Pharmaceuticals

水平: Associate

工作类型: Full-time

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工作内容

Job Description

450 projects straddling discovery through development in PK Sciences (PKS) for you to represent the PK/PD/ADME discipline on discovery and development project teams. As a project team member, you will suggest and implement strategies and tactics to advance high-quality entities as part of the overall program(s).
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 is an enterprise organization, working across both NIBR and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.
The PKS Group at Novartis Institutes of Biomedical Research is seeking a highly motivated drug metabolism and pharmacokinetics scientist. You will have excellent scientific, interpersonal and communication skills, and will effectively operate and influence in a highly matrixed team environment.

Specific Responsibilities
  • The position is responsible for efficient, innovative, and timely preclinical and clinical PK and PK/PD support including but not limited to developing project strategy and supportive study design, analysis, interpretation, and reporting to support international regulatory submissions.
  • Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).
  • Responsible for design, analysis and communication of data on clinical pharmacology studies. Develop and implements new clinical pharmacology studies that impact development programs.
  • Effectively represent clinical pharmacology in cross-functional study-team settings
  • Work in close partnership with Chemistry, Preclinical Toxicology, Project Management, translational medicine, Biostatistics and other partner functional areas to support clinical development programs.
Minimum Requirements
  • PharmD or PhD, with pharmacokinetic training, fellowship and/or postdoctoral experience and 5+ years of clinical pharmacology/pharmacokinetics
  • Strong understanding of clinical pharmacokinetic concepts is required
  • Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable
  • Understanding of discovery and drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs
  • Proficiency in the design and analysis of experiments to define quantitative preclinical PK/PD/efficacy relationships is desired
  • Experience with small molecule and biologic drug discovery and development preferred.
  • Experience with different routes and methods for drug delivery, including inhalation delivery preferred.
  • Ability to leverage modeling and simulation approaches to build an early understanding of predicted human PK, dose and drug/drug interactions.
  • Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable
  • Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills.
Imagine what you could do at Novartis!

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

Division
NIBR

Business Unit
Translational Medicine

Country
Switzerland

Work Location
Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No
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最后期限: 10-05-2024

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