Senior Investigator, PK Sciences

286535BR
Senior Investigator, PK Sciences
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Job Description

Support drug research and development by providing clinical pharmacology/DMPK expertise across early and full development phases, and global medical affairs. Represent PK Sciences on cross-functional teams; influence strategy, design, execution and analysis of clinical pharmacology/DMPK studies; interpret and apply the study results to drug research and development as well as responses to health authorities and investigators.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Represent PK Sciences on local/global project teams: Design and influence clinical pharmacology/DMPK strategy for assigned programs in liaison with appropriate line functions and the Management; coordinate DMPK, PK/PD, biopharmaceutical and M&S activities for preclinical and clinical projects; identify potential project hurdles, suggest solutions, and establish contingency plans.
• Contribute expert input into key preclinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, CTA’s/IND’s and NDA's within agreed timelines and meeting all regulatory requirements under minimal guidance from manager.
• Analyze, interpret and apply DMPK, PK/PD and M&S data to guide clinical development strategy, study design and responses to health authorities
• Present summary information (written and oral) both internally and externally to advisory panels, investigator meetings and health authorities as part of the regulatory approval process.
• Ensure constructive collaboration within drug development teams (EPTs, GPTs, etc.) and with other internal partners (e.g. Toxicology, Formulations, Drug Regulatory Affairs, Clinical Development).
• Monitor timelines, objectives, and as appropriate, program budgets, assure rapid and effective communication of high-quality data and results to project teams.
• Follow internal processes, adhere to Novartis and project-specific standards, and adhere to health authority requirements (e/g., SOPs, Master Analysis Plan, GCP, and regulatory guidelines).
• Maintain and enhance technical and drug development expertise, may act as technical subject matter expert in key clinical pharmacology/DMPK related area.
• Conduct due diligence and prepare appropriate documentation, when needed.
• Coach and mentor other PK Sciences associates

Minimum requirements

What you’ll bring to the role:
• Ph.D./Pharm. D. in a relevant discipline (clinical pharmacology, DMPK, pharmaceuticals) or equivalent experience.
• Fluent English (Oral and Written).
• Associate Director: 7-10 years of relevant postdoctoral, academic, industry or government experience; Manager: 3-7 years of relevant postdoctoral, industry, or government experience.
• Expert knowledge of PK and PK/PD technical tools (e.g., WinNonlin/Pharsight, NONMEM, Monolix, SAS, GastroPlus, SimCyp).
• Expert knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process.
• Demonstrated experience and ability to work successfully as part of cross functional teams in a highly dynamic, matrixed, project-team environment.
• Excellent oral and written communication skills.
• Strong organizational and project skills.
• Excellent critical thinking and problem solving skills, including publications/ presentations.
• Strong influencing and negotiating skills.

Why consider Novartis?
750 million. That’s how many lives our products touch. 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.

We are Novartis. Join us and help us reimagine medicine.

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
NIBR
Translational Medicine
China
Shanghai
CNIBR Co. Ltd.
Research & Development
Full Time
Regular