J****S
发帖数: 15 | 1 Pls contact: d******[email protected] for more information
Manage projects (with a TA focus), interpret and present information and
negotiate an optimal PK/PD strategy for early and late development in
liaison with TA-PK Head and appropriate line functions. Responsible for the
PK, PK/PD and M&S component of study protocols, reports and project
summaries within agreed timeframes and which meet regulatory requirements.
Take the lead on appropriate pharmacokinetic /biopharmaceutical studies.
Major Accountabilities:
• Define PK, PK/PD, biopharmaceutical and M&S requirements in
project (nonclinical and clinical) development plans and appropriate
strategies for global registration.
• Analyze, interpret and represent PK, PK/PD and M&S data generated
during development and provide guidance.
• Proactively manage links with other functions to ensure that pre-
clinical and clinical PK/PD information are used optimally.
• Directly or indirectly take the lead on appropriate
pharmacokinetic/biopharmaceutical studies.
• 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.
• Represent the PK/PD discipline and ensure high quality
interactions with various health authorities, external investigators, and
various internal Disease Area experts
• 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).
• Prepare, compile and review appropriate sections of CTD dossiers
/NDA documents.
• Contribute to and support continuous improvement initiatives in
global pharmacokinetics and partner functions
Requirements:
Education: Ph.D. in Pharmaceutical Sciences, or related disciplines (or
equivalent degree/knowledge/expertise)
Experience: 3-5 years of experiences in drug development or a relevant
environment |
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