TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Director of Clinical Pharmacology and Pharmacometrics

Department :  Global R&D
Working place :  Suzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  10
Minimum academic :  PhD.
Release time :  08 Jul, 2021
Job Responsibilities
  • •Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program and robust registration packages

  • •Play a central role in predicting human dose range, characterizing dose-response relationship and justifying dose recommendations for special populations

  • •Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics

  • •Develop mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance

  • •Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the special populations on PK where appropriate

  • •Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages

  • •Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators

  • •Innovate through working effectively with colleagues in the department and other matrix team members, including: statisticians, biologists, toxicologists and bioanalytical scientists

  • •Learn and apply emerging modeling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality

  • •Promote clinical pharmacology strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences Function as an internal expert in oncology and inflammation/immunology translational medicine. Educate/coach other team members through knowledge sharing. Present and report data in external meetings and publications.

Job Requirements
  • Ph.D. or MD. Experience using modelling tools for quantitative clinical pharmacology such as NONMEM, WINNONLIN, Simcyp, or MATLAB. Experience working with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs.

  • Understanding of pharmacokinetic and pharmacodynamic principles; knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancer and other relevant therapy areas.

  • Effectively work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic