Novartis Job – Senior Investigator Post for Biological Sciences Candidates Vacant
Novartis is a global healthcare leader and has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people.
Job ID : 223299BR
Position Title : Senior Investigator
Country : India
Work Location : Hyderabad
Job Description :
Job Purpose :
Manage projects (with a TA focus). Negotiate an optimal PK/PD strategy for early and full development in liaison with appropriate line functions and with Management input as appropriate. Responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans within agreed timeframes and which meet regulatory requirements. Prepare appropriate responses to HA inquiries (globally) with specific reference to the TA related PK issues in a timely fashion. Interpret and present project related study results and recommend tions to IPTs, TM Management Team and HAs. Take the lead on appropriate pharmacokinetic/ biopharmaceutical studies. Take lead in TM sub-teams and work closely with TM physicians and scientists for successful completion of studies.
1. Define PK, PK/PD, biopharmaceutical and M&S requirements in project development plans and appropriate strategies for global registration.
2. Provide input into TPP relevant to PK, PK-PD and biopharmaceutical aspects.
3. Analyze, interpret and represent PK, PK/PD and M&S data generated during development and provide guidance through recommendations.
4. Present summary information (written and oral) both internally and externally to Advisory panels, Investigator meetings and Health Authorities (only written) as part of the regulatory approval process. This includes PK/PD components of IND applications in the US, CTX in other countries, end of phase II and pre-submission meetings with Health Authorities.
5. Coordinate with appropriate sub-team members and other LF experts for the preparation of, and/ or prepare (when needed) summary documentation on drug metabolism and pharmaco-kinetics as required by ethics committees and HAs (IB, BB, CTA/IND, responses to HAs).
6. Prepare, compile and review appropriate sections of CTD dossiers/NDA documentation.
7. Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally for added value and integrated into early and late phase deve opment plans.
8. Mentor staff as required.
9. Directly or indirectly take the lead on appropriate pharmacokinetic/biopharmaceutical stud-ies.
10. Serve as a key contact person and act as a communication center for all PK related issues (pre-clinical and clinical PK) pertinent to the assigned project.
11. Co-lead the joint PCS sub-team in collaboration with Safety PTR.
12. Ensure the update of project plans and timelines including BAPK and ADME activities in cooperation with BAPK and ADME colleagues.
13. Conduct Due Diligence and prepare appropriate documentation, when needed.
14. Enable study designs for competitive advantage by comparing PK-PD profiles of Novartis compound to that of competitor’s compound.
Minimum requirements :
Ph.D./Pharm.D. level scientist with biological background with 3 years of relevant experience, or Masters Level with at least 5 years relevant experience.
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 tech-niques.
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.
Editors Note: Novartis Recruitment 2017 – All recruitment is done via an online process. Senior Investigator position for Ph.D./Pharm.D. level scientist with biological background with 3 years of relevant experience, or Masters Level with at least 5 years relevant experience is available. More information on job description, job purpose, major accountabilities, educational requirements and experience are all posted above. For more such job opportunities ensure to subscribe to Biotecnika and keep visiting us for more.