A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Investigator II
Job Description
1. Directly or indirectly take the lead on appropriate pharmacokinetic/biopharmaceutical studies.
2. Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally.
3. Provide input into TPP relevant to PK, PK/PD and biopharmaceutical aspects.
4. Co-lead the joint PCS sub-team in collaboration with DMPK PTR.
5. Ensure the update of project plans and timelines including BAPK and ADME activities in cooperation with BAPK and ADME colleagues.
6. Prepare summary information for internal and external Advisory panels, Investigator meetings and Health Authorities as part of the regulatory approval process. This includes PK/PD components of IND applications in the US, CTX in other countries.
7. Coordinate with appropriate sub-team members and other LF experts and/ or prepare (when needed) summary documentation on drug metabolism and pharmacokinetics as required by ethics committees and HAs (IB, BB, CTA/IND, responses to HAs).
8. Prepare and compile appropriate sections of CTD dossiers /NDA documents.
9. Enable study designs for competitive advantage by comparing PK/PD profiles of Novartis compounds to that of competitor’s compounds.
Candidate Profile
Ph.D./Pharm.D. level scientist with biological back ground with 3 years of relevant experience, or Masters Level with at least 5 years relevant experience. Fluent English (oral and written). At least 5 years experience in drug development or a relevant environment (e.g. Clinical Pharmacology or Drug Metabolism and Pharmacokinetics).
1. Proven knowledge of PK and PK/PD evaluation techniques.
2. Experience of working in project teams (preferably global) and sound awareness of recent developments in drug development sciences essential.
3. Knowledge of regulatory requirements and experience in dealing with regulatory authorities.
Additional Information:
Job ID: 148566BR
Experience: Min. 5 Year
Industry Type: Pharma/Biotech/Clinical Research
Location: India
Functional Area: R&D
End Date: 28th October, 2014
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