Senior Investigator I, PK Oncology

243369BR
Senior Investigator I, PK Oncology
You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.
You will lead the PK Sciences strategy and influence project strategy during discovery and/or clinical program. You will collaborate within the cross-functional team to identify and mitigate key project issues related to the PK Sciences discipline (PK, PK/PD, IG, metabolism and clinical pharmacology).

Your responsibilities will include:

1. Independently represent PK Sciences as a core member of discovery, Translational Medicine and global project teams.
2. Participate or lead PKS sub-team to define PKS strategy for compound progression and development.
3. Manage study timelines, objectives and budgets, ensureing accuracy of project progress in company tracking tools.
4. Timely and effective communication of data, strategy, results, impact to the project teams.
5. Align plans and strategies with sub-teams, project teams, manager and leadership team.
6. Analyze and interpret PK/TK/PD/IG data generated during discovery, early and full development; present results to the program.
7. Proactively identify potential project hurdles, provide solutions and contribute to contingency plans.
8. Independently author and prepare key pre-clinical, clinical and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs - within agreed timelines, and meeting all regulatory requirements.
9. Actively participate in cross-departmental teams, department-wide initiatives and work streams.
10. Provide PK Sciences expertise on due diligence and prepare appropriate documentation.
11. Publish internally or externally as main contributor to enhance Novartis and PK Sciences visibility.
12. May mentor and train other PK Science Associates.
13. Complete all required organizational trainings and requirements according to corporate timelines
14. Adhere in strict accord to the appropriate SOP and GxP guidelines.

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Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide.

Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application.

PK Sciences (PKS) is part of TM and partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D.
- PhD or Pharm.D with relevant experience in drug metabolism and pharmacokinetics or related biologic background.
- Fluent English (oral and written)
- 8+ years of experience in drug discovery, development or a relevant environment (e.g. Clinical Pharmacology or Drug Metabolism and Pharmacokinetics).
- Extensive and in-depth knowledge of scientific discipline specially in drug metabolism and pharmacokinetics.
- Demonstrated success of working in cross functional project teams (preferably global) and sound awareness of recent developments in drug development sciences.
- Knowledge of regulatory requirements and experience in dealing with regulatory authorities.
- Proficient with full range of techniques used in job and core area.
- Extensive library research skills.
- Working knowledge of tools and processes used in drug design and development.
- Sound and robust list of scientific publications.
NIBR
Translational Medicine
Switzerland
Basel
Switzerland Novartis Pharma AG, Basel
Research & Development
Full Time
Regular